Atlas FDA

FLEXON AND STAINLESS STEEL SUTURES

FDA 510(k) clearance K930992 · decided 1993-12-17

Clearance details

K-number
K930992
Device name
FLEXON AND STAINLESS STEEL SUTURES
Applicant
American Cyanamid Co.
Decision
Substantially Equivalent
Date received
1993-02-25
Decision date
1993-12-17
Days to decision
295 days
Clearance type
Traditional
Product code
GAQ
Device class
2
Regulation number
878.4495
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Danbury, CT, US
Third-party review
No
Expedited review
No

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FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (K140127)Pontis Orthopaedics, LLC2014-05-28
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (K081060)Core Essence Orthopaedics, LLC2008-12-24
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MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (K042606)Synthes (Usa)2005-05-27
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SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE (K032468)Suturtek Incorporated2003-09-23

Recalls involving this device

No recalls on record reference this clearance.