The following data is part of a premarket notification filed by Stiefel Research Institute, Inc. with the FDA for Cryojet Liquid Nitrogen Spray Cryosurgical Instru..
| Device ID | K896724 |
| 510k Number | K896724 |
| Device Name: | CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU. |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Contact | Carr, Jr |
| Correspondent | Carr, Jr STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-29 |
| Decision Date | 1990-01-09 |