The following data is part of a premarket notification filed by Anthogyr with the FDA for Instrument Kits.
Device ID | K160730 |
510k Number | K160730 |
Device Name: | Instrument Kits |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | ANTHOGYR 2237 Avenue Andre Lasquin Sallanches, FR 74700 |
Contact | Therese Candau |
Correspondent | Therese Candau ANTHOGYR 2237 Avenue Andre Lasquin Sallanches, FR 74700 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-16 |
Decision Date | 2017-04-27 |
Summary: | summary |