The following data is part of a premarket notification filed by Schoelly Technologies, Inc. with the FDA for Laparoscope, Rod-lens Viewing And Operating Endoscope.
| Device ID | K951990 |
| 510k Number | K951990 |
| Device Name: | LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SCHOELLY TECHNOLOGIES, INC. TWO OAKWOOD BLVD. SUITE 160 Hollywood, FL 33020 |
| Contact | Kenneth J Durbin |
| Correspondent | Kenneth J Durbin SCHOELLY TECHNOLOGIES, INC. TWO OAKWOOD BLVD. SUITE 160 Hollywood, FL 33020 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-09-08 |