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510(k) K891471

SIL-MED WASTE FLUID DUMP BAG by Sil-Med Corp. — Product Code KDG

K891471 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "SIL-MED WASTE FLUID DUMP BAG". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code KDG (Chisel (Osteotome)), a Class I device regulated under 21 CFR 878.4820. Sil-Med Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
March 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel (Osteotome)
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Sil-Med Corp.

  • K972521 — NAVIGATOR (STYLET) 2006 (October 1, 1997)
  • K961392 — ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II (July 18, 1997)
  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (June 26, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K955463 — GRIP-A-BOOTS (January 23, 1996)
  • K942709 — MEDIASTINAL SILICONE DRAINS (January 4, 1996)
  • K926496 — SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN (May 24, 1995)
  • K926495 — SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE (February 2, 1994)
  • K926408 — SIL-SLIP FLAT SUCTION DRAIN (February 2, 1994)

Other clearances for product code KDG

  • K952678 — STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (July 10, 1995)
  • K952200 — OMNI-JUG (June 29, 1995)
  • K894785 — SURGICAL CHISEL/OSTEOTOME (August 18, 1989)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K872092 — OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (June 23, 1987)
  • K842824 — CHERMEL BONE CHISELS (August 2, 1984)
  • K772374 — SILVER OSTEOTOME (March 9, 1978)
  • K772376 — NEIVERT OSTEOTOME (March 9, 1978)
  • K772373 — ANDERSON-NEIVERT OSTEOTOME (March 9, 1978)
  • K780135 — CEMENT EXTRACTION INSTRUMENT SET (January 31, 1978)

FDA data resources