The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Gusberg Hysterectomy Clamp.
| Device ID | K771344 |
| 510k Number | K771344 |
| Device Name: | GUSBERG HYSTERECTOMY CLAMP |
| Classification | Clamp, Uterine |
| Applicant | J. SKLAR MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGC |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-13 |
| Decision Date | 1977-07-27 |