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510(k) K041580

IMAGERAYI by Henry Schein, Inc. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2004
Date Received
June 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Henry Schein, Inc.

  • K862384 — SCHEIN AP-1 AIR POLISHING UNIT (November 7, 1986)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 1984)
  • K834055 — VANADIUM EXCAVATORS SIZES 0-6 (February 21, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)
  • K781592 — SURGICAL ASPIRATOR TIPS (December 4, 1978)

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