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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceNON-ABSORBABLE BLACK SILK SUTURE
Generic NameMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
Regulation Number868.2600
ApplicantLook, Inc.
2020 Lonnie Abbott Ind. Blvd.
Ada, OK 74820
PMA NumberN83074
Supplement NumberS004
Date Received07/31/1990
Decision Date09/12/1990
Product Code CAP 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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