The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Maid Mentor Aspiration/irrigation Devro.
Device ID | K853382 |
510k Number | K853382 |
Device Name: | MAID MENTOR ASPIRATION/IRRIGATION DEVRO |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | MENTOR O & O, INC. SOUTH SHORE PARK Hingham, MA 02043 |
Contact | David M Link |
Correspondent | David M Link MENTOR O & O, INC. SOUTH SHORE PARK Hingham, MA 02043 |
Product Code | HQE |
CFR Regulation Number | 886.4150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-12 |
Decision Date | 1985-10-04 |