The following data is part of a premarket notification filed by Hamilton Industries, Inc. with the FDA for Comficare Pad (for Singel Pt Use).
Device ID | K792001 |
510k Number | K792001 |
Device Name: | COMFICARE PAD (FOR SINGEL PT USE) |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | HAMILTON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-05 |
Decision Date | 1979-10-26 |