The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Laser Continuous Flow Tesectoscope (cfr).
| Device ID | K936038 |
| 510k Number | K936038 |
| Device Name: | SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) |
| Classification | Resectoscope |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
| Contact | Thomas Becze |
| Correspondent | Thomas Becze SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
| Product Code | FJL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1994-05-27 |