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510(k) K190383

GM501 Wash by Hamilton Thorne, Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2019
Date Received
February 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by Hamilton Thorne, Inc.

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  • K191552 — GM501 Mineral Oil (September 18, 2019)
  • K120055 — HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED (April 24, 2012)

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