The following data is part of a premarket notification filed by Specialty Medical Systems, Inc. with the FDA for Endoflush System 1.0, 2.o, 3.0.
| Device ID | K935207 |
| 510k Number | K935207 |
| Device Name: | ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SPECIALTY MEDICAL SYSTEMS, INC. P.O. BOX 16598 Ft. Worth, TX 76162 -0598 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer SPECIALTY MEDICAL SYSTEMS, INC. P.O. BOX 16598 Ft. Worth, TX 76162 -0598 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-29 |
| Decision Date | 1994-04-21 |