The following data is part of a premarket notification filed by Health Aid Products with the FDA for Hemorest(tm).
Device ID | K864470 |
510k Number | K864470 |
Device Name: | HEMOREST(TM) |
Classification | Cushion, Hemorrhoid |
Applicant | HEALTH AID PRODUCTS 5881 N.W. 151ST ST. SUITE 101A Miami Lakes, FL 33014 |
Contact | Paul Salver |
Correspondent | Paul Salver HEALTH AID PRODUCTS 5881 N.W. 151ST ST. SUITE 101A Miami Lakes, FL 33014 |
Product Code | LRL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-12 |
Decision Date | 1987-06-23 |