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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ThinPrep 2000 Slide Processor; ThinPrep 5000 Processor; ThinPrep Genesis Processor; ThinPrep Gynecological Filters; ThinPrep Gynecological Preservative (PreservCyt); ThinPrep Gynecological Slides; ThinPrep® CERV(TM) Gynecological Filters; ThinPrep® CERV(TM) PreservCyt® Solution
Classification Name: READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Product Code: MNM
Device Class: 3
Registered Establishment Name: Hologic, Inc.
Registered Establishment Number: 1221855
Premarket Submission Number: P950039
Owner/Operator: HOLOGIC, INC.
Owner/Operator Number: 9007676
Establishment Operations: Manufacturer
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