ORTHOPHOS 3/ ORTHOPHOS 3C— 510(k) K936068

Substantially Equivalent

Pelton & Crane Co.

FDA 510(k) clearance K936068 for ORTHOPHOS 3/ ORTHOPHOS 3C, Substantially Equivalent on 1994-07-29. Applicant: Pelton & Crane Co.. Device class: 2.

Clearance details

Applicant: Pelton & Crane Co.
Product code: Code EAP
Device class: Class 2
Regulation: 21 CFR 872.1810
Advisory panel: Dental
Date received: 1993-12-21
Decision date: 1994-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Pelton & Crane Co.

K972249 — ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD1997-09-12
K972168 — SIDEXIS DIGITAL RADIOGRAPHY SYSTEM1997-09-05
K945117 — DELTA1997-02-28
K962071 — SPIRIT S1/S21996-08-06
K960819 — HELIODENT DS1996-03-29

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