The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Pharmaseal Alternating Pressure Pad System.
Device ID | K872228 |
510k Number | K872228 |
Device Name: | PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
Contact | Larry W Getlin |
Correspondent | Larry W Getlin AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-09 |
Decision Date | 1987-09-04 |