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Precept Medical Products, Inc.

Arden, NC, US

Precept Medical Products, Inc. appears in FDA device records in Arden, NC. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Precept Medical Products, Inc. in 2002.

Clearances by year, as a table
510(k) clearance decisions for Precept Medical Products, Inc., by decision year
YearClearances
20021
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K013846ULTRAGARD IMPERVIOUS REINFORCED GOWNFYASubstantially 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-0154-2008Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320, non-sterile, 25/box, 6 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, MexicoSmall slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staffTerminated
Z-0153-2008Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3322, non-sterile, 50/box, 5 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, MexicoSmall slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staffTerminated

Verification record

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