The following data is part of a premarket notification filed by Generic Medical Device, Inc. with the FDA for Gmd Universal Circumcision Clamp, Model 200.
| Device ID | K063429 |
| 510k Number | K063429 |
| Device Name: | GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 |
| Classification | Clamp, Circumcision |
| Applicant | GENERIC MEDICAL DEVICE, INC. 3906 ROSELAND ST. Houston, TX 77006 |
| Contact | Monica Montanez |
| Correspondent | Monica Montanez GENERIC MEDICAL DEVICE, INC. 3906 ROSELAND ST. Houston, TX 77006 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2007-01-17 |
| Summary: | summary |