The following data is part of a premarket notification filed by Microsurgical Technology, Inc. with the FDA for Infusion Cannula.
Device ID | K942403 |
510k Number | K942403 |
Device Name: | INFUSION CANNULA |
Classification | Cannula, Ophthalmic |
Applicant | MICROSURGICAL TECHNOLOGY, INC. P.O. BOX 675 Kirkland, WA 98083 |
Contact | Isidro Nilsson |
Correspondent | Isidro Nilsson MICROSURGICAL TECHNOLOGY, INC. P.O. BOX 675 Kirkland, WA 98083 |
Product Code | HMX |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-19 |
Decision Date | 1994-08-17 |