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510(k) K932333

PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR by Gull Laboratories, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1995
Date Received
May 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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  • K922759 — HSV-2 IGM ELISA TEST--MODIFICATION (October 5, 1992)
  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)

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