RAND SURGICAL SPONGE— 510(k) K971178

Substantially Equivalent

Trans Aire

FDA 510(k) clearance K971178 for RAND SURGICAL SPONGE, Substantially Equivalent on 1997-06-27. Applicant: Trans Aire. Device class: Unclassified.

Clearance details

Applicant: Trans Aire
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-03-31
Decision date: 1997-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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