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510(k) K834055

VANADIUM EXCAVATORS SIZES 0-6 by Henry Schein, Inc. — Product Code EKC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
November 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Excavator, Dental, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 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)

Other clearances for product code EKC

  • K851722 — 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (July 2, 1985)