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510(k) K780471

GASTRIC LAVAGE KIT by Gaymar Industries, Inc. — Product Code FAT

K780471 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "GASTRIC LAVAGE KIT". The FDA issued a decision of Substantially Equivalent on June 2, 1978. The device falls under product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology), a Class II device regulated under 21 CFR 876.5365. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1978
Date Received
March 24, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

Other clearances by Gaymar Industries, Inc.

  • K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 (January 20, 2011)
  • K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
  • K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (April 30, 1997)
  • K963067 — SOF. PRESS EPC 51 SYSTEM (January 28, 1997)
  • K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212 (August 9, 1996)
  • K942881 — TC 3000 (May 23, 1995)
  • K930345 — TC2000 POWER UNIT AND ACCESSORIES (August 6, 1993)
  • K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
  • K914805 — TC-1000, TC-1050 SYSTEM (January 7, 1992)
  • K914851 — CLA-1400 SYSTEM (November 13, 1991)

Other clearances for product code FAT

  • K133439 — PILLING ESOPHAGEAL BOUGIES (June 16, 2014)
  • K983220 — STRYKER INFRAVISION ESOPHAGEAL KIT (June 4, 1999)
  • K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (February 2, 1998)
  • K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (June 27, 1996)
  • K901425 — PYLORIC BALLOON DILATOR (June 21, 1990)
  • K843186 — ESKA MULTISTAGE ESOPHAGEAL BOUGIE (January 18, 1985)
  • K842679 — ESOPHAGEAL DILATOR SET (October 2, 1984)

FDA data resources