The following data is part of a premarket notification filed by Soprane S.a. with the FDA for Fertiloscopy Kit Fh 1.29/fto 1.40.
| Device ID | K992655 |
| 510k Number | K992655 |
| Device Name: | FERTILOSCOPY KIT FH 1.29/FTO 1.40 |
| Classification | Culdoscope (and Accessories) |
| Applicant | SOPRANE S.A. 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein SOPRANE S.A. 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | HEW |
| Subsequent Product Code | HET |
| Subsequent Product Code | HIH |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-09 |
| Decision Date | 2000-03-13 |
| Summary: | summary |