The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000.
| Device ID | K950495 |
| 510k Number | K950495 |
| Device Name: | SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | SURGICAL DYNAMICS, INC. 2575 STANWELL DR. Concord, CA 94520 |
| Contact | Larry Dobesh |
| Correspondent | Larry Dobesh SURGICAL DYNAMICS, INC. 2575 STANWELL DR. Concord, CA 94520 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-05-09 |