The following data is part of a premarket notification filed by United Surgical Corp. with the FDA for Non-sterile, Extra Plus Pak Cat. #uspk 2100.
| Device ID | K870806 |
| 510k Number | K870806 |
| Device Name: | NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 |
| Classification | Unit, Phacofragmentation |
| 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 | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-26 |
| Decision Date | 1987-03-26 |