The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Cotton Roll Compression Caps.
Device ID | K792391 |
510k Number | K792391 |
Device Name: | COTTON ROLL COMPRESSION CAPS |
Classification | Cotton, Roll |
Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFN |
CFR Regulation Number | 872.6050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-26 |
Decision Date | 1979-12-06 |