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510(k) K760851

CONVERSE ALTAR RETRACTOR by V. Mueller O.V. Baxter Healthcare Corp. — Product Code KAL

K760851 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "CONVERSE ALTAR RETRACTOR". The FDA issued a decision of Substantially Equivalent on March 10, 1977. The device falls under product code KAL (Retractor, Ent), a Class I device regulated under 21 CFR 874.4420. 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
March 10, 1977
Date Received
October 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Ent
Device Class
Class I
Regulation Number
874.4420
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)
  • K770959 — BOUGIE, FILIFORM, JACKSON (June 14, 1977)
  • K770280 — CORD, ELECTROSURGICAL-STERILE & DISPOS. (April 15, 1977)
  • K761242 — TEFLON COATED RESECTOSCOPE SHEATH (December 16, 1976)
  • K760273 — LITHOTRITE (December 6, 1976)
  • K760180 — FORCEPS, GRASPING (December 2, 1976)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)

Other clearances for product code KAL

  • K870758 — SMALL MASTOID RETRACTOR (March 4, 1987)
  • K833604 — ADJUSTABLE FORK RETRACTOR (January 3, 1984)
  • K772381 — RING HANDLE & RETRACTORS (January 17, 1978)
  • K772392 — ALLPORT MASTOID RETRACTORS (January 17, 1978)

FDA data resources