HEARING AID(ALL IN THE EAR(ALL IN THE CANAL— 510(k) K852052

Name: FDA 510(k) clearance K852052
Creator: U.S. Food and Drug Administration
Published: 1985-08-16

Substantially Equivalent for Some Indications

Penn-Tech Laboratories

FDA 510(k) clearance K852052 for HEARING AID(ALL IN THE EAR(ALL IN THE CANAL, Substantially Equivalent for Some Indications on 1985-08-16. Applicant: Penn-Tech Laboratories. Device class: 1.

Clearance details

Applicant: Penn-Tech Laboratories
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1985-05-09
Decision date: 1985-08-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Williamsport, PA, US

Download summary PDF View on FDA.gov ↗

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