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510(k) K921564

POLYCLEAN by Medical Polymers, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1992
Date Received
April 1, 1992
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

Other clearances by Medical Polymers, Inc.

  • K941365 — MPI DENTURE ADHESIVE FILM SEALS (April 22, 1994)
  • K934666 — PDS ULTRACLEAN (April 15, 1994)

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