The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for United Surgical Corp. Cryoptic Plus.
Device ID | K870195 |
510k Number | K870195 |
Device Name: | UNITED SURGICAL CORP. CRYOPTIC PLUS |
Classification | Unit, Cryophthalmic |
Applicant | UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine, CA 92718 |
Contact | Terry F Herbeck |
Correspondent | Terry F Herbeck UNITED SURGICAL CORP. 15500-A ROCKFIELD BLVD. Irvine, CA 92718 |
Product Code | HPS |
CFR Regulation Number | 886.4170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-20 |
Decision Date | 1987-02-20 |