The following data is part of a premarket notification filed by Hill-med, Inc. with the FDA for Hm-cryo.
| Device ID | K940140 |
| 510k Number | K940140 |
| Device Name: | HM-CRYO |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | HILL-MED, INC. 7217 N.W. 46TH ST. Miami, FL 33166 |
| Contact | Ernesto Ackerman |
| Correspondent | Ernesto Ackerman HILL-MED, INC. 7217 N.W. 46TH ST. Miami, FL 33166 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-11 |
| Decision Date | 1994-06-27 |