The following data is part of a premarket notification filed by Interpro Intl., Inc. with the FDA for Guaze Sponges.
Device ID | K874067 |
510k Number | K874067 |
Device Name: | GUAZE SPONGES |
Classification | Gauze/sponge, Internal |
Applicant | INTERPRO INTL., INC. 2 VIEWPOINT TERRACE Lebanon, NJ 08833 |
Contact | Wayne R Knupp |
Correspondent | Wayne R Knupp INTERPRO INTL., INC. 2 VIEWPOINT TERRACE Lebanon, NJ 08833 |
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 | 1987-10-05 |
Decision Date | 1987-12-14 |