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510(k) K822516

VIVONEX MASS GASTRASTOMY TUBE by Norwich Eaton Pharmaceuticals, Inc. — Product Code KHT

K822516 is an FDA 510(k) premarket notification submitted by Norwich Eaton Pharmaceuticals, Inc. for the device "VIVONEX MASS GASTRASTOMY TUBE". The FDA issued a decision of Substantially Equivalent on September 7, 1982. The device falls under product code KHT (Fraction V, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5370. Norwich Eaton Pharmaceuticals, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1982
Date Received
August 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fraction V, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5370
Review Panel
IM
Submission Type

Other clearances by Norwich Eaton Pharmaceuticals, Inc.

  • K842841 — VIVONEX TUNG STEN TIP TUBE (August 14, 1984)
  • K831969 — VIVONEX TUNGSTEN TIP TUBE-WOUND (September 1, 1983)
  • K831968 — VIVONEX TUNGSTEN TIP TUBE-BRAIDED (September 1, 1983)
  • K831971 — VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRE (September 1, 1983)
  • K831970 — VIVONEX TUNGSTEN TIP TUBE-MONOFILA- (July 18, 1983)
  • K821231 — VIVONEX TUNGSTEN TIP TUBE PLACEMENT (May 10, 1982)
  • K821067 — VIVONEX ACUTROL ENTERNAL FEEDING SYS (April 29, 1982)
  • K811968 — VIVONEX TUNGSTEN TIP (August 25, 1981)
  • K802300 — VIVONEX JEJUNOSTOMY KIT (October 23, 1980)

FDA data resources