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510(k) K920539

ORWO X-RAY FILM by Burkhart Roentgen Intl., Inc. — Product Code IWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1992
Date Received
February 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Film, Radiographic
Device Class
Class I
Regulation Number
892.1840
Review Panel
RA
Submission Type

Other clearances by Burkhart Roentgen Intl., Inc.

  • K920538 — PROTECTIVE RADIOGRAFIC GLOVE (May 29, 1992)
  • K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD (May 28, 1992)

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