510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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The Sewing Source, Inc.

Spring Hope, NC, US

The Sewing Source, Inc. appears in FDA device records in Spring Hope, NC. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 9 510(k) clearances for The Sewing Source, Inc. between 1993 and 1996. The busiest year on record is 1993, with 8. The most recent is 1996, with 1.

Clearances by year, as a table
510(k) clearance decisions for The Sewing Source, Inc., by decision year
YearClearances
19938
19961
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K960045ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPEKKXSubstantially Equivalent
K921158O.R./SURGEONS GOWN, ITEM NO. 4950FYASubstantially Equivalent
K921157O.R./SURGEONS GOWN, ITEM NO. 4942FYASubstantially Equivalent
K921156O.R./SURGEONS GOWN, ITEM NO.4941FYASubstantially Equivalent
K921155O.R./SURGEONS GOWN, ITEM NO. 4962FYASubstantially Equivalent
K921154O.R./SURGEONS GOWN, ITEM NO. 4962FYASubstantially Equivalent
K921153O.R./SURGEONS GOWN, ITEM NO. 4960FYASubstantially Equivalent
K921152O.R./SURGEONS GOWN, ITEM NO. 4952FYASubstantially Equivalent
K921151O.R./SURGEONS GOWN, ITEM NO. 4951FYASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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