The following data is part of a premarket notification filed by Universal Health Care Products Canada, Inc. with the FDA for Pads Menstrual, Untreat Deodorized, Various Sizes.
Device ID | K933879 |
510k Number | K933879 |
Device Name: | PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES |
Classification | Pad, Menstrual, Unscented |
Applicant | UNIVERSAL HEALTH CARE PRODUCTS CANADA, INC. 870 ELLINGHAM ST., POINTE CLAIRE Quebec H9r 3s4, CA |
Contact | Dave Lockhart |
Correspondent | Dave Lockhart UNIVERSAL HEALTH CARE PRODUCTS CANADA, INC. 870 ELLINGHAM ST., POINTE CLAIRE Quebec H9r 3s4, CA |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-09 |
Decision Date | 1994-03-24 |