The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Ophthalmic Cautery.
Device ID | K945493 |
510k Number | K945493 |
Device Name: | OPHTHALMIC CAUTERY |
Classification | Unit, Cautery, Thermal, Battery-powered |
Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
Contact | J R Saron |
Correspondent | J R Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
Product Code | HQP |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-01 |
Decision Date | 1995-01-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887482177518 | K945493 | 000 |
00887482177105 | K945493 | 000 |