The following data is part of a premarket notification filed by General Medical Co. with the FDA for Laparotomy Spogne.
Device ID | K772089 |
510k Number | K772089 |
Device Name: | LAPAROTOMY SPOGNE |
Classification | Gauze/sponge, Internal |
Applicant | GENERAL MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
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 | 1977-11-04 |
Decision Date | 1977-11-11 |