The following data is part of a premarket notification filed by Emergo Group, Inc. with the FDA for Smart Klamp Various By Size.
| Device ID | K032091 |
| 510k Number | K032091 |
| Device Name: | SMART KLAMP VARIOUS BY SIZE |
| Classification | Clamp, Circumcision |
| Applicant | EMERGO GROUP, INC. 2454 MCMULLEN BOOTH ROAD SUITE 427 Clerwater, FL 33759 |
| Contact | Rene' Van De Zande |
| Correspondent | Rene' Van De Zande EMERGO GROUP, INC. 2454 MCMULLEN BOOTH ROAD SUITE 427 Clerwater, FL 33759 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-07 |
| Decision Date | 2004-03-08 |
| Summary: | summary |