The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for Free Choice.
Device ID | K963032 |
510k Number | K963032 |
Device Name: | FREE CHOICE |
Classification | Tampon, Menstrual, Unscented |
Applicant | FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale, NJ 07401 |
Contact | Robert J Staab |
Correspondent | Robert J Staab FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE 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 | 1996-08-05 |
Decision Date | 1996-10-11 |
Summary: | summary |