The following data is part of a premarket notification filed by Microsurgical Technology, Inc. with the FDA for Inter Tip T.
Device ID | K934844 |
510k Number | K934844 |
Device Name: | INTER TIP T |
Classification | Cannula, Ophthalmic |
Applicant | MICROSURGICAL TECHNOLOGY, INC. 723-B 9TH AVE. Kirkland, WA 98033 |
Contact | Susan P Aylesworth |
Correspondent | Susan P Aylesworth MICROSURGICAL TECHNOLOGY, INC. 723-B 9TH AVE. Kirkland, WA 98033 |
Product Code | HMX |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-08 |
Decision Date | 1994-04-19 |