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510(k) K003184

RS BIOTECH GALAXY 'R' CO2 INCUBATOR by Zander Medical Supplies, Inc. — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2000
Date Received
October 11, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type

Other clearances by Zander Medical Supplies, Inc.

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  • K002971 — MTG - MINITUB HEATED STAGE SYSTEMS (December 15, 2000)
  • K002961 — MINITUB MULTI-PURPOSE CASSETTES (November 21, 2000)

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