The following data is part of a premarket notification filed by O'tec Corp. with the FDA for Scc22/ Scc26 Shower Commode Chair.
Device ID | K943293 |
510k Number | K943293 |
Device Name: | SCC22/ SCC26 SHOWER COMMODE CHAIR |
Classification | Wheelchair, Mechanical |
Applicant | O'TEC CORP. P.O. BOX 320 204 W. 2ND ST. Ellis, KS 67637 |
Contact | Lee Frickey |
Correspondent | Lee Frickey O'TEC CORP. P.O. BOX 320 204 W. 2ND ST. Ellis, KS 67637 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-08 |
Decision Date | 1994-08-19 |