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510(k) K833586

TLS BULB DRAINAGE SYSTEM by Porex Medical — Product Code GCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
October 12, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class
Class I
Regulation Number
878.4680
Review Panel
SU
Submission Type

Other clearances by Porex Medical

  • K872791 — POREX NERVE LOCATOR (October 20, 1987)
  • K873044 — POREX OTOLOGY INSTRUMENTS (September 4, 1987)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT (February 27, 1987)
  • K863943 — POREX(TM) EYE SPHERE IMPLANT (February 27, 1987)
  • K870257 — POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T. (February 24, 1987)
  • K870154 — POREX(TM) TISSUE EXPANDER (February 24, 1987)
  • K870182 — POREX(TM) MALAR IMPLANT (February 24, 1987)
  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)
  • K863942 — POREX(TM) NOSE PROSTHESIS (October 24, 1986)

Other clearances for product code GCY

  • K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEM (October 1, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (December 12, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K950754 — MACRO SUCTION TUBE MODEL NO 10061 (April 25, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K930615 — AUTOVAC CLOSED WOUND SUCTION SYSTEM (February 22, 1994)
  • K933319 — BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE (October 27, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)