The following data is part of a premarket notification filed by Surgi-quip Inc.u with the FDA for Wee Bag O'mercury.
Device ID | K840004 |
510k Number | K840004 |
Device Name: | WEE BAG O'MERCURY |
Classification | Applicator, Ocular Pressure |
Applicant | SURGI-QUIP INC.U 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LCC |
CFR Regulation Number | 886.4610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-04 |
Decision Date | 1984-03-22 |