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510(k) K852160

RADIOLOGICAL MARKING PEN by Truett Laboratories, Inc. — Product Code JAC

K852160 is an FDA 510(k) premarket notification submitted by Truett Laboratories, Inc. for the device "RADIOLOGICAL MARKING PEN". The FDA issued a decision of Substantially Equivalent on July 18, 1985. The device falls under product code JAC (System, X-Ray, Film Marking, Radiographic), a Class I device regulated under 21 CFR 892.1640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1985
Date Received
February 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Film Marking, Radiographic
Device Class
Class I
Regulation Number
892.1640
Review Panel
RA
Submission Type

Other clearances for product code JAC

  • K942883 — DIGITAL I.D. CAMERA (September 30, 1994)
  • K930752 — CT/MRI TOPOGRAPHIC MARKER (November 19, 1993)
  • K932357 — FUJI EC ID CAMERA (July 26, 1993)
  • K925892 — SOLSTICE XRAY RING MARKER PAD (May 18, 1993)
  • K923533 — ADMARK (March 4, 1993)
  • K926404 — KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L (March 4, 1993)
  • K924345 — RADIOGRAPHIC FILM MARKETING SYSTEM (November 27, 1992)
  • K925332 — BENNETT X-RAY ID PLUS (November 27, 1992)
  • K920031 — KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE (February 12, 1992)
  • K915088 — KODAK MIN-R IDENTIFICATION CAMERA (December 2, 1991)

FDA data resources