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510(k) K874596

PERFORATED SOAKING TUBE by Specialty Medical Products Co. — Product Code GBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1987
Date Received
November 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Specialty Medical Products Co.

  • K924707 — VARIOUS ANESTHETIC KITS OR TRAYS (June 17, 1993)
  • K922533 — IV START KIT CUSTOM SMP # A-Z (March 23, 1993)
  • K922845 — BASIC DRESSING CHANGE TRAY SMP 102A (December 29, 1992)

Other clearances for product code GBQ

  • K941356 — MICROFLOW IRRIGATION SYSTEM (May 19, 1994)
  • K921464 — CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT (May 5, 1992)
  • K882647 — GESCO CATHETERIZATION TRAY (September 9, 1988)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K872787 — MODIFIED CURLCATH (August 4, 1987)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K771732 — THORNTON ANTERIOR CHAMBER IRRIGATOR (September 28, 1977)