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510(k) K952678

STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT by Avail-Southwest Division — Product Code KDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1995
Date Received
June 12, 1995
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 Avail-Southwest Division

  • K950830 — STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (1 (May 3, 1995)
  • K933520 — ENDOSCOPIC ANTI-FOG KIT, 100-302-00 (August 24, 1993)
  • K864158 — THERMAPAD (March 2, 1987)

Other clearances for product code KDG

  • K952200 — OMNI-JUG (June 29, 1995)
  • K894785 — SURGICAL CHISEL/OSTEOTOME (August 18, 1989)
  • K891471 — SIL-MED WASTE FLUID DUMP BAG (August 15, 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)
  • K772376 — NEIVERT OSTEOTOME (March 9, 1978)
  • K772373 — ANDERSON-NEIVERT OSTEOTOME (March 9, 1978)
  • K772374 — SILVER OSTEOTOME (March 9, 1978)
  • K780135 — CEMENT EXTRACTION INSTRUMENT SET (January 31, 1978)