The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Sequential Pressure Cuff.
Device ID | K771083 |
510k Number | K771083 |
Device Name: | SEQUENTIAL PRESSURE CUFF |
Classification | Sleeve, Limb, Compressible |
Applicant | GAYMAR INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-16 |
Decision Date | 1977-07-21 |