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510(k) K921730

C-SECTION PACK by Medikmark, Inc. — Product Code KOH

K921730 is an FDA 510(k) premarket notification submitted by Medikmark, Inc. for the device "C-SECTION PACK". The FDA issued a decision of Substantially Equivalent on June 15, 1994. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520. Medikmark, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1994
Date Received
April 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, General Obstetric-Gynecologic
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

Other clearances by Medikmark, Inc.

  • K953474 — IV START KIT (October 2, 1995)
  • K923960 — UPPER EXTERMITY DRAPE KIT (October 7, 1994)
  • K921733 — TRACHEOSTOMY CARE TRAY (June 15, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K920339 — DRESSING CHANGE TRAY (April 23, 1992)
  • K920341 — LACERATION TRAYS (April 23, 1992)
  • K920340 — SUTURE REMOVAL KIT (April 23, 1992)

Other clearances for product code KOH

  • K000212 — KSEA CHARDONNES MORCELLATION KNIFE (April 21, 2000)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K892693 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (May 11, 1989)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K891035 — NEEDLE EXTENSIONS (March 22, 1989)
  • K891049 — ZEPPELIN SCISSORS (March 17, 1989)
  • K863610 — THE OB-GYN CONCEPTS VAGINAL ASPIRATOR (January 7, 1987)
  • K840308 — CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (March 5, 1984)
  • K823792 — QUARTZ RETRACTOR/PROBE (January 18, 1983)
  • K812204 — UTERINE MANIPULATORS (October 13, 1981)

FDA data resources