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510(k) K837515

DENTAL CASSETTE HOLDERS by Xre Corp.

K837515 is an FDA 510(k) premarket notification submitted by Xre Corp. for the device "DENTAL CASSETTE HOLDERS". The FDA issued a decision of Substantially Equivalent on June 28, 1983. Xre Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1983
Date Received
April 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Xre Corp.

  • K973744 — UNICATH SP BI-PLANE (MODEL M269 & M289) (December 29, 1997)
  • K961193 — FULL FRAME ZOOM SYSTEM (June 17, 1996)
  • K960998 — XRE COLLIMATOR (April 3, 1996)
  • K945449 — UNICATH LLU ANGIOGRAPHIC SYSTEM (February 27, 1995)
  • K936002 — CINEMAC QAS (September 9, 1994)
  • K933460 — DVFX, MODEL M256 (April 7, 1994)
  • K924828 — BI-N (December 17, 1992)
  • K923654 — POLY DIAGNOST CDX (November 20, 1992)
  • K913685 — UNICATH EP. (November 7, 1991)
  • K912416 — ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM (August 28, 1991)

FDA data resources