The following data is part of a premarket notification filed by Alto Development Corp. with the FDA for Raney Clip.
Device ID | K884783 |
510k Number | K884783 |
Device Name: | RANEY CLIP |
Classification | Clip, Removable (skin) |
Applicant | ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727 |
Contact | Alex Wojciechowicz |
Correspondent | Alex Wojciechowicz ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727 |
Product Code | FZQ |
CFR Regulation Number | 878.4320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-15 |
Decision Date | 1988-11-30 |