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510(k) K012535

DRG DISPOSABLE VAGINAL SPECULUM by Doctor'S Research Group, Inc. — Product Code HIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2002
Date Received
August 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Nonmetal
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Doctor'S Research Group, Inc.

  • K051487 — DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE (December 22, 2005)
  • K041018 — DRG SOFTRELEASE (October 18, 2004)
  • K012003 — DRG REACTION CHAMBER/SAFETY TIP (February 12, 2002)
  • K011736 — DRG QUICKMIX (January 30, 2002)
  • K013786 — DRG ORTHOHEX SS BONE SCREW (December 17, 2001)
  • K002047 — DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT (November 22, 2000)
  • K991714 — DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 (December 10, 1999)
  • K990212 — LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 (September 14, 1999)
  • K990920 — DRG TITANIUM BONE PLATE (June 10, 1999)
  • K981881 — DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRIL (December 2, 1998)

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  • K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM (February 8, 2008)
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