The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Handidam.
Device ID | K884828 |
510k Number | K884828 |
Device Name: | HANDIDAM |
Classification | Dam, Rubber |
Applicant | ASEPTICO, INC. P.O. BOX 3209 Kirkland, WA 98083 |
Contact | Douglas H Kazen |
Correspondent | Douglas H Kazen ASEPTICO, INC. P.O. BOX 3209 Kirkland, WA 98083 |
Product Code | EIE |
CFR Regulation Number | 872.6300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-18 |
Decision Date | 1989-02-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HANDIDAM 76455866 2820813 Live/Registered |
Aseptico, Inc. 2002-10-04 |