The following data is part of a premarket notification filed by Synemed, Inc. with the FDA for Scope Master.
| Device ID | K811270 |
| 510k Number | K811270 |
| Device Name: | SCOPE MASTER |
| Classification | Hysteroscope (and Accessories) |
| Applicant | SYNEMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-06 |
| Decision Date | 1981-09-08 |