The following data is part of a premarket notification filed by Central Plastic, Inc. with the FDA for Anti-fog Disposable Iv Induction Cover.
Device ID | K910104 |
510k Number | K910104 |
Device Name: | ANTI-FOG DISPOSABLE IV INDUCTION COVER |
Classification | Protector, Wound, Plastic |
Applicant | CENTRAL PLASTIC, INC. P.O. BOX 789 Eldorado, KS 67042 |
Contact | Charles Greenwell |
Correspondent | Charles Greenwell CENTRAL PLASTIC, INC. P.O. BOX 789 Eldorado, KS 67042 |
Product Code | EYF |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-03 |
Decision Date | 1991-04-12 |