The following data is part of a premarket notification filed by Noritage, Inc. with the FDA for King Krib.
Device ID | K934298 |
510k Number | K934298 |
Device Name: | KING KRIB |
Classification | Bed, Manual |
Applicant | NORITAGE, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
Contact | Carolann Kotula-cook |
Correspondent | Carolann Kotula-cook NORITAGE, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
Product Code | FNJ |
CFR Regulation Number | 880.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-02 |
Decision Date | 1994-01-26 |