The following data is part of a premarket notification filed by Pedicraft, Inc. with the FDA for Pedicragt Bassinet.
Device ID | K925949 |
510k Number | K925949 |
Device Name: | PEDICRAGT BASSINET |
Classification | Bed, Pediatric Open Hospital |
Applicant | PEDICRAFT, INC. 2014 PERRY PLACE Jacksonville, FL 32207 |
Contact | Eric Nord |
Correspondent | Eric Nord PEDICRAFT, INC. 2014 PERRY PLACE Jacksonville, FL 32207 |
Product Code | FMS |
CFR Regulation Number | 880.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-24 |
Decision Date | 1993-04-20 |