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510(k) K861198

CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES) by Quali-Med, Inc.

K861198 is an FDA 510(k) premarket notification submitted by Quali-Med, Inc. for the device "CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)". The FDA issued a decision of Substantially Equivalent with Drug on May 16, 1986. Quali-Med, Inc. has 6 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent with Drug)
Decision Date
May 16, 1986
Date Received
Mar 31, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Quali-Med, Inc.

  • K871408 — BLOOD VESSEL CONNECTOR (Apr 27, 1987)
  • K862972 — DISPOSABLE MIRROR (Sep 23, 1986)
  • K862472 — QUARTZ RODS TITANIUM RODS (Sep 12, 1986)
  • K862241 — STANDARD BASIN KIT CUSTOM BASIN KIT (Aug 1, 1986)
  • K862242 — PAP SMEAR KIT (Jun 26, 1986)
  • K862172 — QUALI-MED'S OPERATING ROOM DRAPES (Jun 19, 1986)

FDA data resources