CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE— 510(k) K853091

Name: FDA 510(k) clearance K853091
Creator: U.S. Food and Drug Administration
Published: 1986-01-21

Substantially Equivalent

Psp Dental Co., Ltd.

FDA 510(k) clearance K853091 for CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE, Substantially Equivalent on 1986-01-21. Applicant: Psp Dental Co., Ltd.. Device class: 2.

Clearance details

Applicant: Psp Dental Co., Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1985-07-23
Decision date: 1986-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belvedere, Kent, GB

Download summary PDF View on FDA.gov ↗

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