The following data is part of a premarket notification filed by Professional Pharmacy West, Inc. with the FDA for Vip's Prophylactics, Natural, Anatomic & Femina.
Device ID | K871300 |
510k Number | K871300 |
Device Name: | VIP'S PROPHYLACTICS, NATURAL, ANATOMIC & FEMINA |
Classification | Condom |
Applicant | PROFESSIONAL PHARMACY WEST, INC. 567 KING ST. Charleston, SC 29403 |
Contact | Barry Bloom |
Correspondent | Barry Bloom PROFESSIONAL PHARMACY WEST, INC. 567 KING ST. Charleston, SC 29403 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-01 |
Decision Date | 1987-06-08 |