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510(k) K873097

PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS by Ipax, Inc. — Product Code GBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
July 27, 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

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Other clearances for product code GBQ

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  • K882647 — GESCO CATHETERIZATION TRAY (September 9, 1988)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)
  • K872787 — MODIFIED CURLCATH (August 4, 1987)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K771732 — THORNTON ANTERIOR CHAMBER IRRIGATOR (September 28, 1977)