ANSWER DENTAL IMPLEMENTS, MIRROR— 510(k) K894895

Name: FDA 510(k) clearance K894895
Creator: U.S. Food and Drug Administration
Published: 1989-10-30

Substantially Equivalent

Tern Chien Ent. Co., Ltd.

FDA 510(k) clearance K894895 for ANSWER DENTAL IMPLEMENTS, MIRROR, Substantially Equivalent on 1989-10-30. Applicant: Tern Chien Ent. Co., Ltd.. Device class: 1.

Clearance details

Applicant: Tern Chien Ent. Co., Ltd.
Product code: Code EKJ
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1989-08-01
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findlay, OH, US

Download summary PDF View on FDA.gov ↗

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K894896 — ANSWER DENTAL IMPLEMENT, EXPLORER1989-10-30
K894897 — ANSWER DENTAL IMPLEMENT, FORCEPS1989-10-30

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