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510(k) K873177

DEVINE (SUPRAPUBIC SOUND AND GUIDE) by Penn Medical Devices, Inc. — Product Code KOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1987
Date Received
August 12, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
Submission Type

Other clearances by Penn Medical Devices, Inc.

  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K873176 — HUFFMAN BIOPSY UNIT (October 14, 1987)
  • K873178 — URETERAL BULB DILATORS (September 30, 1987)
  • K871667 — URETERAL STENT (June 10, 1987)
  • K870508 — GASTROINTESTINAL TUBE (May 11, 1987)
  • K862729 — PENN 3-RING HANDLE (October 24, 1986)
  • K862107 — PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR (September 11, 1986)

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  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K961904 — AQ HYDROPHILIC DILATORS (October 18, 1996)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K920551 — 120 FR OPTILUME PROSTATE BALLOON DILATOR (October 28, 1992)
  • K922349 — DOWD(TM) II (August 14, 1992)
  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)