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510(k) K912327

DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. by Davis Lead Aprons, Inc. — Product Code KPY

K912327 is an FDA 510(k) premarket notification submitted by Davis Lead Aprons, Inc. for the device "DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.". The FDA issued a decision of Substantially Equivalent on March 18, 1992. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. Davis Lead Aprons, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
May 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Protective, Personnel
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Davis Lead Aprons, Inc.

  • K912326 — DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (March 18, 1992)
  • K912378 — DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS (March 18, 1992)

Other clearances for product code KPY

  • K110900 — DISPOSABLE THYROID COLLAR (June 24, 2011)
  • K962622 — INTRA-ORAL THERMOPLASTIC SHIELD (October 1, 1996)
  • K954456 — THERMOPLASTIC SHIELD (December 21, 1995)
  • K954146 — UTK-DTE AUTILARY SHIELD (December 6, 1995)
  • K953610 — AUKULYTE (September 26, 1995)
  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)
  • K940539 — STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM (March 16, 1994)
  • K934206 — MAVIG ANGIO SHIELD MODELS 6290 & 6272 (October 7, 1993)
  • K912326 — DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS (March 18, 1992)

FDA data resources