The following data is part of a premarket notification filed by Microsurgical Technology, Inc. with the FDA for Phaco Handpiece For Phaco Fragmentation Machines, Phaco Sleeve For Attachment To Phaco Handpieces.
| Device ID | K953959 |
| 510k Number | K953959 |
| Device Name: | PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES |
| Classification | Unit, Phacofragmentation |
| Applicant | MICROSURGICAL TECHNOLOGY, INC. P.O. BOX 2679 8415 154TH AVENUE NE Redmond, WA 98052 |
| Contact | Ed Terpilowski |
| Correspondent | Ed Terpilowski MICROSURGICAL TECHNOLOGY, INC. P.O. BOX 2679 8415 154TH AVENUE NE Redmond, WA 98052 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-11-17 |