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510(k) K852943

NEO SHIELD by Gaymar Industries, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1985
Date Received
July 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

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  • K914805 — TC-1000, TC-1050 SYSTEM (January 7, 1992)
  • K914851 — CLA-1400 SYSTEM (November 13, 1991)

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