The following data is part of a premarket notification filed by Ultrafem, Inc. with the FDA for Instead, Softcup.
| Device ID | K971303 |
| 510k Number | K971303 |
| Device Name: | INSTEAD, SOFTCUP |
| Classification | Cup, Menstrual |
| Applicant | ULTRAFEM, INC. 1050 CONNECTICUT AVE., N.W. Washington, DC 20036 -5339 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz ULTRAFEM, INC. 1050 CONNECTICUT AVE., N.W. Washington, DC 20036 -5339 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-08 |
| Decision Date | 1997-06-06 |