The following data is part of a premarket notification filed by Salt Creek Medical Technologies with the FDA for S.c.m.t. Perforator.
| Device ID | K871087 |
| 510k Number | K871087 |
| Device Name: | S.C.M.T. PERFORATOR |
| Classification | Amniotome |
| Applicant | SALT CREEK MEDICAL TECHNOLOGIES 5500 ARAPAHO PASS Pinckney, MI 48169 |
| Contact | Howard Meade |
| Correspondent | Howard Meade SALT CREEK MEDICAL TECHNOLOGIES 5500 ARAPAHO PASS Pinckney, MI 48169 |
| Product Code | HGE |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-18 |
| Decision Date | 1987-03-23 |