The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Finger Cots.
Device ID | K821028 |
510k Number | K821028 |
Device Name: | FINGER COTS |
Classification | Patient Examination Glove |
Applicant | ABCO DEALERS, INC. WI |
Product Code | FMC |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-13 |
Decision Date | 1982-04-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FINGER COTS 73342573 not registered Dead/Abandoned |
QUALITY RUBBER PRODUCTS INCORPORATED 0000-00-00 |