The following data is part of a premarket notification filed by Clinical Innovations, Llc with the FDA for Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision Device.
| Device ID | K061539 |
| 510k Number | K061539 |
| Device Name: | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE |
| Classification | Clamp, Circumcision |
| Applicant | CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH Murray, UT 84123 |
| Contact | Wm Dean Wallace |
| Correspondent | Wm Dean Wallace CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH Murray, UT 84123 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-05 |
| Decision Date | 2007-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814247020097 | K061539 | 000 |
| 20814247020073 | K061539 | 000 |
| 20814247020059 | K061539 | 000 |
| 00814247020031 | K061539 | 000 |