TWIST PPAGC-1, TWIST PP— 510(k) K972543

Substantially Equivalent

Trutone

FDA 510(k) clearance K972543 for TWIST PPAGC-1, TWIST PP, Substantially Equivalent on 1997-07-23. Applicant: Trutone. Device class: 1.

Clearance details

Applicant: Trutone
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1997-07-09
Decision date: 1997-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

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More clearances from Trutone

K973377 — SIBELMED AC50D1998-03-10
K972550 — AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC1997-07-31
K972552 — AUDIFON H20 PC/AUDIFON H32 PP1997-07-30
K972542 — JAZZ PP AGC-O, JAZZ PP1997-07-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.