The following data is part of a premarket notification filed by Regu-tech Assoc., Inc. with the FDA for Femtex 100% Cotton Tampons.
| Device ID | K971228 |
| 510k Number | K971228 |
| Device Name: | FEMTEX 100% COTTON TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | REGU-TECH ASSOC., INC. 73 FRANKLIN TPK. Allendale, NJ 07401 |
| Contact | Robert J Staab |
| Correspondent | Robert J Staab REGU-TECH ASSOC., INC. 73 FRANKLIN TPK. Allendale, NJ 07401 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-04-09 |
| Summary: | summary |