The following data is part of a premarket notification filed by Gottfried Medical, Inc. with the FDA for Water Floatation Pad.
Device ID | K820236 |
510k Number | K820236 |
Device Name: | WATER FLOATATION PAD |
Classification | Cushion, Flotation |
Applicant | GOTTFRIED MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KIC |
CFR Regulation Number | 890.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-28 |
Decision Date | 1982-02-04 |