The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Disposable Co2 Absorber/e.
Device ID | K897171 |
510k Number | K897171 |
Device Name: | DISPOSABLE CO2 ABSORBER/E |
Classification | Absorbent, Carbon-dioxide |
Applicant | GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
Contact | Paul E Dryden |
Correspondent | Paul E Dryden GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
Product Code | CBL |
CFR Regulation Number | 868.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-28 |
Decision Date | 1990-03-13 |