The following data is part of a premarket notification filed by Un-i-med, Inc. with the FDA for Hann-vac Tm, Disposable,suction Catheter.
Device ID | K903480 |
510k Number | K903480 |
Device Name: | HANN-VAC TM, DISPOSABLE,SUCTION CATHETER |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | UN-I-MED, INC. 6507 SOUTH 400 WESTT Murray, UT 84107 |
Contact | Robert Greenwall |
Correspondent | Robert Greenwall UN-I-MED, INC. 6507 SOUTH 400 WESTT Murray, UT 84107 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-02 |
Decision Date | 1991-10-01 |