The following data is part of a premarket notification filed by Koninklijke (royal) Utermohlen with the FDA for Utermohlen Cryo Professional.
| Device ID | K152203 |
| 510k Number | K152203 |
| Device Name: | UTERMOHLEN CRYO PROFESSIONAL |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | KONINKLIJKE (ROYAL) UTERMOHLEN DEE OVERWEG 1 Wolvega, NL 8471za |
| Contact | Mr.d Van Hoof |
| Correspondent | Dr K R Michael KRM ASSOCIATES 17751 FRONDOSA DRIVE San Diego, CA 92128 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-06 |
| Decision Date | 2015-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717484792841 | K152203 | 000 |
| 08717484790502 | K152203 | 000 |
| 08717484790526 | K152203 | 000 |
| 08717484790533 | K152203 | 000 |
| 08717484790540 | K152203 | 000 |
| 08717484792780 | K152203 | 000 |
| 08717484792810 | K152203 | 000 |
| 08717484792827 | K152203 | 000 |
| 08717484792834 | K152203 | 000 |
| 08717484790496 | K152203 | 000 |