Atlas FDA

SUTURES POLYPROP., POLYETHELINE, NYLON & SILK

FDA 510(k) clearance K930739 · decided 1994-07-26

Clearance details

K-number
K930739
Device name
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
Applicant
Deknatel, Inc.
Decision
Substantially Equivalent
Date received
1993-02-12
Decision date
1994-07-26
Days to decision
529 days
Clearance type
Traditional
Product code
GAP
Device class
2
Regulation number
878.5030
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
San Jose-Heredia, CR
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #83 recall (Z-1018-2007)Teleflex Creek Dr2007-07-17

PMA approvals by this applicant

RecordFirmDate
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S006)Deknatel, Inc.1989-06-16
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S007)Deknatel, Inc.1989-06-16
DEKLENE(TM) (P810028/S011)Deknatel, Inc.1989-06-16
DEKLENE(TM) (P810028/S010)Deknatel, Inc.1989-02-02
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S005)Deknatel, Inc.1989-01-31
DEKLENE(TM) (P810028/S008)Deknatel, Inc.1989-01-31
CHROMIC GUT SUTURE (N84381/S007)Deknatel, Inc.1989-01-31
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S004)Deknatel, Inc.1989-01-31