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510(k) K970704

PERSONAL CATHETER by Rochester Medical Corp. — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1997
Date Received
February 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Rochester Medical Corp.

  • K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER (May 14, 2013)
  • K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SY (June 10, 2004)
  • K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (July 7, 2000)
  • K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-H (May 19, 2000)
  • K981612 — ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, T (July 8, 1998)
  • K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER (January 13, 1998)
  • K952082 — ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (July 18, 1995)
  • K941692 — FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER (March 6, 1995)
  • K943851 — ALL SILICONE INTERMITTENT CATHETER (January 31, 1995)
  • K923136 — MALE EXTERNAL CATHETER (December 3, 1992)

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