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 |