NON-ABSORBABLE BLACK SILK SUTURE

FDA Premarket Approval N83074 S004

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 BLACK SILK SUTURE
Generic NameMonitor, Airway Pressure (includes Gauge And/or Alarm)
ApplicantLOOK, INC.
Date Received1990-07-31
Decision Date1990-09-12
PMAN83074
SupplementS004
Product CodeCAP 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address LOOK, INC. 2020 Lonnie Abbott Ind. Blvd. ada, OK 74820

Supplemental Filings

Supplement NumberDateSupplement Type
N83074Original Filing
S004 1990-07-31 Normal 180 Day Track
S003
S002 1986-03-21
S001 1984-07-10

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