The following data is part of a premarket notification filed by New Medical Technologies Gmbh with the FDA for Cryosuccess, Model C-suc-01, C-suc-02, C-dts-02, C-dts-03, C-gts-13. C-ca-23.
| Device ID | K091721 |
| 510k Number | K091721 |
| Device Name: | CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | NEW MEDICAL TECHNOLOGIES GMBH 1710 ROMANO DRIVE Plymouth Meeting, PA 19462 |
| Contact | Vince D'alessandro |
| Correspondent | Vince D'alessandro NEW MEDICAL TECHNOLOGIES GMBH 1710 ROMANO DRIVE Plymouth Meeting, PA 19462 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-11 |
| Decision Date | 2009-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H834335211 | K091721 | 000 |
| H834335181 | K091721 | 000 |
| H834335221 | K091721 | 000 |
| H834335111 | K091721 | 000 |
| H834335121 | K091721 | 000 |
| H834335131 | K091721 | 000 |
| H834335141 | K091721 | 000 |
| H834335151 | K091721 | 000 |
| H834335161 | K091721 | 000 |
| H834335171 | K091721 | 000 |
| H834335191 | K091721 | 000 |
| H834335201 | K091721 | 000 |
| H834335101 | K091721 | 000 |