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510(k) K952200

OMNI-JUG by Waterstone Medical, Inc. — Product Code KDG

K952200 is an FDA 510(k) premarket notification submitted by Waterstone Medical, Inc. for the device "OMNI-JUG". The FDA issued a decision of Substantially Equivalent on June 29, 1995. The device falls under product code KDG (Chisel (Osteotome)), a Class I device regulated under 21 CFR 878.4820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1995
Date Received
May 10, 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 for product code KDG

  • K952678 — STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (July 10, 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)
  • K772374 — SILVER OSTEOTOME (March 9, 1978)
  • K772373 — ANDERSON-NEIVERT OSTEOTOME (March 9, 1978)
  • K780135 — CEMENT EXTRACTION INSTRUMENT SET (January 31, 1978)

FDA data resources