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510(k) K760357

SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI) by V. Mueller O.V. Baxter Healthcare Corp. — Product Code FZG

K760357 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI)". The FDA issued a decision of Substantially Equivalent on October 27, 1976. The device falls under product code FZG (Apparatus, Air Handling, Bench), a Class II device regulated under 21 CFR 878.5070. 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
October 27, 1976
Date Received
August 2, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Air Handling, Bench
Device Class
Class II
Regulation Number
878.5070
Review Panel
SU
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)
  • 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)

FDA data resources