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510(k) K932761

SOFT-WEAR HEADGEAR AND SAFETY MODULES by Professional Positioners, Inc. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1993
Date Received
June 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

Other clearances by Professional Positioners, Inc.

  • K943905 — PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER (February 27, 1995)
  • K932298 — PRO'S NEO-LASTICS (February 14, 1994)

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