The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Huntleigh Double Bubble Air-o-pad-aop5.
Device ID | K882644 |
510k Number | K882644 |
Device Name: | HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
Contact | James Britton |
Correspondent | James Britton HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-27 |
Decision Date | 1988-08-10 |