The following data is part of a premarket notification filed by Creative Medical Laboratories, Inc. with the FDA for Tugs-transportable Univ. Gradient Suct.
Device ID | K843081 |
510k Number | K843081 |
Device Name: | TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT |
Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
Applicant | CREATIVE MEDICAL LABORATORIES, INC. P.O. BOX 6347 |
Contact | Allen W Moberg |
Correspondent | Allen W Moberg CREATIVE MEDICAL LABORATORIES, INC. P.O. BOX 6347 |
Product Code | JCX |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-06 |
Decision Date | 1984-10-11 |