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510(k) K862334

CATALOG NO. I/A 100 AND KPE 200 by Ipax, Inc.

K862334 is an FDA 510(k) premarket notification submitted by Ipax, Inc. for the device "CATALOG NO. I/A 100 AND KPE 200". The FDA issued a decision of Substantially Equivalent on July 8, 1986. Ipax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1986
Date Received
June 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Ipax, Inc.

  • K200893 — ProntoPump Sterile Tube Set (May 4, 2021)
  • K971242 — BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) (December 17, 1997)
  • K971245 — BLINK EXTERNAL EYELID WEIGHT (June 20, 1997)
  • K915158 — SUREBREATH DOME, E-Z BREATHER (February 12, 1992)
  • K915118 — PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE (December 27, 1991)
  • K914172 — KPE 230 AM (October 25, 1991)
  • K914221 — KPE 220 TS, NONSTERILE (October 25, 1991)
  • K884076 — SUREBREATH DOME (October 7, 1988)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K870770 — TIMLEINE(TM) VENIPUNCTURE SYSTEM (April 23, 1987)

FDA data resources