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510(k) K770959

BOUGIE, FILIFORM, JACKSON by V. Mueller O.V. Baxter Healthcare Corp. — Product Code KBI

K770959 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "BOUGIE, FILIFORM, JACKSON". The FDA issued a decision of Substantially Equivalent on June 14, 1977. The device falls under product code KBI (Bougie, Eustachian), a Class I device regulated under 21 CFR 874.4175. V. Mueller O.V. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1977
Date Received
May 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bougie, Eustachian
Device Class
Class I
Regulation Number
874.4175
Review Panel
EN
Submission Type

Other clearances by V. Mueller O.V. Baxter Healthcare Corp.

  • K803292 — FIELD SUCTION DISSECTOR (January 29, 1981)
  • K792383 — KELMAN DIPSTICK (December 11, 1979)
  • K771197 — NORTON ENDOTRACHEAL (August 16, 1977)
  • K771302 — PFISTER-SCHWARTZ STONE RETRIEVER (August 2, 1977)
  • K770280 — CORD, ELECTROSURGICAL-STERILE & DISPOS. (April 15, 1977)
  • K760851 — CONVERSE ALTAR RETRACTOR (March 10, 1977)
  • K761242 — TEFLON COATED RESECTOSCOPE SHEATH (December 16, 1976)
  • K760273 — LITHOTRITE (December 6, 1976)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)
  • K760184 — ELEMENT, WORKING (December 2, 1976)

FDA data resources