The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Medi-frig.
Device ID | K954703 |
510k Number | K954703 |
Device Name: | MEDI-FRIG |
Classification | Unit, Cryosurgical, Accessories |
Applicant | ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
Contact | Richard C Lanzillotto |
Correspondent | Richard C Lanzillotto ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
Product Code | GEH |
CFR Regulation Number | 878.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-12 |
Decision Date | 1996-02-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841494103866 | K954703 | 000 |
00841494103224 | K954703 | 000 |
10841494105133 | K954703 | 000 |