The following data is part of a premarket notification filed by Microsurgical Technology, Inc. with the FDA for Wee Bag O'mercury.
Device ID | K946194 |
510k Number | K946194 |
Device Name: | WEE BAG O'MERCURY |
Classification | Applicator, Ocular Pressure |
Applicant | MICROSURGICAL TECHNOLOGY, INC. 723-B 9TH AVE. Kirkland, WA 98033 |
Contact | Isidro Nilsson |
Correspondent | Isidro Nilsson MICROSURGICAL TECHNOLOGY, INC. 723-B 9TH AVE. Kirkland, WA 98033 |
Product Code | LCC |
CFR Regulation Number | 886.4610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-20 |
Decision Date | 1995-02-27 |