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510(k) K962527

GENERAL PURPOSE DENTAL TRAY by Medcare Medical Group, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1996
Date Received
June 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Medcare Medical Group, Inc.

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  • K961075 — MEDCARE REGIONAL ANETHESIA KIT (September 6, 1996)
  • K962328 — SINGLE USE INSTRUMENT TRAY (August 9, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K961167 — MEDCARE TRACHEOSTOMY CARE TRAY (July 2, 1996)

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