The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Sterile Laparotomy Gauze Sponge.
| Device ID | K862126 |
| 510k Number | K862126 |
| Device Name: | STERILE LAPAROTOMY GAUZE SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Contact | Kathy Russell |
| Correspondent | Kathy Russell ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| 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 | 1986-06-04 |
| Decision Date | 1986-06-19 |