The following data is part of a premarket notification filed by Air Liquide Healthcare America Corporation with the FDA for Pure Cryogen.
| Device ID | K153564 |
| 510k Number | K153564 |
| Device Name: | PURE CRYOGEN |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AIR LIQUIDE HEALTHCARE AMERICA CORPORATION 12800 WEST LITTLE YORK ROAD Houston, TX 77041 |
| Contact | Steve Miller |
| Correspondent | Michael Hinckle K&L GATES LLP 430 DAVIS DRIVE, SUITE 400 Morrisville, NC 27560 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2016-03-29 |
| Summary: | summary |