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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spatula, cervical, cytological
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeHHT
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGENE CORP.
  SUBSTANTIALLY EQUIVALENT 1
HARDWOOD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE, GMBH
  SUBSTANTIALLY EQUIVALENT 1
UNIMAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 1
Detachment of device or device component 1
Total Device Problems 2

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