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510(k) K802004

PROFILE SWAB CAT.#5273 & 5274 by Pollak (Intl.), Ltd. — Product Code KXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type

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