NON-ABSORBABLE (POLYESTER FIBER) SUTURES

FDA Premarket Approval N83509 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceNON-ABSORBABLE (POLYESTER FIBER) SUTURES
Generic NameSuture, Nonabsorbable, Synthetic, Polyester
ApplicantDAVIS & GECK, INC.
Date Received1980-12-16
Decision Date1981-07-20
PMAN83509
SupplementS002
Product CodeGAS 
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address DAVIS & GECK, INC. 1 Casper St. danbury, CT 06810

Supplemental Filings

Supplement NumberDateSupplement Type
N83509Original Filing
S011 1987-04-14 Normal 180 Day Track
S010 1986-12-05 Normal 180 Day Track
S009 1986-10-02 Normal 180 Day Track
S008 1986-07-01 Normal 180 Day Track
S007 1982-12-29
S006 1982-06-17
S005 1982-06-17
S004 1981-12-15
S003
S002 1980-12-16
S001 1980-02-01

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