The following data is part of a premarket notification filed by Hospital Specialty Co. with the FDA for Gards Deodorant Sanitary Napkin.
Device ID | K882094 |
510k Number | K882094 |
Device Name: | GARDS DEODORANT SANITARY NAPKIN |
Classification | Pad, Menstrual, Scented |
Applicant | HOSPITAL SPECIALTY CO. 7501 CARNEGIE AVE. Cleveland, OH 44103 -4896 |
Contact | Robert A May |
Correspondent | Robert A May HOSPITAL SPECIALTY CO. 7501 CARNEGIE AVE. Cleveland, OH 44103 -4896 |
Product Code | HHL |
CFR Regulation Number | 884.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-19 |
Decision Date | 1988-09-22 |