SPS DISK— 510(k) K812084

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K812084 for SPS DISK, Substantially Equivalent on 1981-08-13. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1981-07-22
Decision date: 1981-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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