The following data is part of a premarket notification filed by Greenwald Surgical Co., Inc. with the FDA for Clamp, Incontinence, Baumrucker.
| Device ID | K780137 |
| 510k Number | K780137 |
| Device Name: | CLAMP, INCONTINENCE, BAUMRUCKER |
| Classification | Clamp, Penile |
| Applicant | GREENWALD SURGICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FHA |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-25 |
| Decision Date | 1978-04-28 |