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Chattem, Inc.

Chattanooga, TN, US

Chattem, Inc. appears in FDA device records in Chattanooga, TN. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
3
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Chattem, Inc. in 2013.

Clearances by year, as a table
510(k) clearance decisions for Chattem, Inc., by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K131159SMARTRELIEFNUHSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1198-2008Aspercreme, Pain Relieving Creme with Aloe, Maximum Strength Formula, Net Wt 3oz (85g) with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually wrapped patch, 3.9" x 5.3" (10cm x 13.5cm), Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219Skin irritation and burns with product usageTerminated
Z-1197-2008Icy Hot Heat Therapy , Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm) each, 1 and 4 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219Skin irritation and burns with product usageTerminated
Z-1196-2008Icy Hot Heat Therapy , Air Activated Heat Patch, Back and Large Areas, UPC Code 0-41167-08330-7, Product Code 08330, 4.1" x 8.4" (10.5 cm x 2.1 cm) each, 1 and 3 count patches, Distributed by Chattem, Inc. P.O. Box 2219, Chattanooga, TN 37409-0219Skin irritation and burns with product usageTerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain