BIO-97— 510(k) K991901

Substantially Equivalent

Jeneric/Pentron, Inc.

FDA 510(k) clearance K991901 for BIO-97, Substantially Equivalent on 1999-09-07. Applicant: Jeneric/Pentron, Inc.. Device class: 2.

Clearance details

Applicant: Jeneric/Pentron, Inc.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 1999-06-04
Decision date: 1999-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJT

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K012231 — AVANTE MICRO CRYSTAL SYSTEM2001-08-23
K011748 — FIRST FILL R.C.S.2001-08-03

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