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510(k) K780407

2C7125 BLOW BOTTLE by Travenol Laboratories, S.A. — Product Code BYO

K780407 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "2C7125 BLOW BOTTLE". The FDA issued a decision of Substantially Equivalent on April 10, 1978. The device falls under product code BYO (Bottle, Blow), a Class I device regulated under 21 CFR 868.5220. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Blow
Device Class
Class I
Regulation Number
868.5220
Review Panel
AN
Submission Type

Other clearances by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

Other clearances for product code BYO

  • K924541 — EPIDURAL MINIPACK (July 9, 1993)
  • K913527 — HYPERFREE (January 21, 1992)
  • K780558 — BOTTLE BREATHING DEVICE (May 26, 1978)

FDA data resources