The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Zeppelin Forceps.
| Device ID | K901897 |
| 510k Number | K901897 |
| Device Name: | ZEPPELIN FORCEPS |
| Classification | Forceps, Surgical, Gynecological |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
| Contact | Kirwan, Jr. |
| Correspondent | Kirwan, Jr. KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
| Product Code | HCZ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-25 |
| Decision Date | 1990-06-29 |