The following data is part of a premarket notification filed by Gmp/companies, Inc. with the FDA for Laparocision Scope Controller System.
| Device ID | K050027 |
| 510k Number | K050027 |
| Device Name: | LAPAROCISION SCOPE CONTROLLER SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GMP/COMPANIES, INC. ONE EAST BROWARD BLVD. SUITE 1701 Fort Lauderdale, FL 33301 |
| Contact | Ralph Jugo |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-06 |
| Decision Date | 2005-01-27 |
| Summary: | summary |