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 |