The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for Chevron Tape Dissector, 9/16 X 1/4, 9/16 X 1/8.
Device ID | K872808 |
510k Number | K872808 |
Device Name: | CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 |
Classification | Gauze/sponge, Internal |
Applicant | AMERICAN SILK SUTURES, INC. 57 MUNROE ST. Lynn, MA 01901 |
Contact | Ed Greenspan |
Correspondent | Ed Greenspan AMERICAN SILK SUTURES, INC. 57 MUNROE ST. Lynn, MA 01901 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-14 |
Decision Date | 1987-08-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20749915000722 | K872808 | 000 |