STERI-DENT, STERI-SURE— 510(k) K094026

Substantially Equivalent

Cpac, Inc.

FDA 510(k) clearance K094026 for STERI-DENT, STERI-SURE, Substantially Equivalent on 2011-07-12. Applicant: Cpac, Inc.. Device class: 2.

Clearance details

Applicant: Cpac, Inc.
Product code: Code KMH
Device class: Class 2
Regulation: 21 CFR 880.6870
Advisory panel: General Hospital
Date received: 2009-12-30
Decision date: 2011-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leicester, NY, US

Download summary PDF View on FDA.gov ↗

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K881371 — COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE1988-04-13

More clearances from Cpac, Inc.

K110867 — STERI-DENT, STERI-SURE2011-07-20
K781486 — STERI-VAC POWER UNITS1978-09-27
K771070 — DRY HEAT STERILIZER1977-07-14
K771071 — PORTO-VAC1977-07-14

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