The following data is part of a premarket notification filed by Anodyne Corp. with the FDA for Anolift - Portable & Anolift - Gantry.
Device ID | K902141 |
510k Number | K902141 |
Device Name: | ANOLIFT - PORTABLE & ANOLIFT - GANTRY |
Classification | Lift, Patient, Non-ac-powered |
Applicant | ANODYNE CORP. 4023 SOUTH U.S. 23, SUITE #106 Brighton, MI 48116 |
Contact | Donald D Merry |
Correspondent | Donald D Merry ANODYNE CORP. 4023 SOUTH U.S. 23, SUITE #106 Brighton, MI 48116 |
Product Code | FSA |
CFR Regulation Number | 880.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-15 |
Decision Date | 1990-09-12 |