The following data is part of a premarket notification filed by Surgical Design, Inc. with the FDA for Surgical Design Circumcision Clamp.
| Device ID | K043533 |
| 510k Number | K043533 |
| Device Name: | SURGICAL DESIGN CIRCUMCISION CLAMP |
| Classification | Clamp, Circumcision |
| Applicant | SURGICAL DESIGN, INC. 7351-D LOCKPORT PL. Lorton, VA 22079 |
| Contact | Mohammad Bashir |
| Correspondent | Mohammad Bashir SURGICAL DESIGN, INC. 7351-D LOCKPORT PL. Lorton, VA 22079 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-22 |
| Decision Date | 2005-04-01 |
| Summary: | summary |