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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device colposcope (and colpomicroscope)
Regulation Description Colposcope.
Product CodeHEX
Regulation Number 884.1630
Device Class 2


Premarket Reviews
ManufacturerDecision
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELMED
  SUBSTANTIALLY EQUIVALENT 1
FORTH PHOTONICS HELLAS SA
  SUBSTANTIALLY EQUIVALENT 1
GYNEX CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDGYN
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
SOMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SOUNMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
STI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
UNITED PRODUCTS & INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 4
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2

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