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510(k) K790087

LUBRICANT, OTRHO PERSONAL by Ortho Pharmaceutical Corp. — Product Code KMJ

K790087 is an FDA 510(k) premarket notification submitted by Ortho Pharmaceutical Corp. for the device "LUBRICANT, OTRHO PERSONAL". The FDA issued a decision of Substantially Equivalent on February 1, 1979. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Ortho Pharmaceutical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
January 17, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Patient
Device Class
Class I
Regulation Number
880.6375
Review Panel
HO
Submission Type

Other clearances by Ortho Pharmaceutical Corp.

  • K955648 — K-Y PERSONAL LUBRICANT (June 21, 1996)
  • K934516 — ADVANCE PREGNANCY TEST MODIFICATION (February 24, 1994)
  • K914990 — ADVANCE(R) PREGNANCY TEST (December 23, 1991)
  • K893488 — PULSATILE PUMP FOR GONADORELIN ACETATE (October 31, 1989)
  • K881151 — MICROSCRAPE (April 6, 1988)
  • K810581 — FACT* HOME PREGNANCY TEST (March 17, 1981)
  • K800754 — NICKERSON'S MED. SELECTIVE CULTURE MEDIU (April 29, 1980)
  • K792634 — CONCEPTROL/THIN PROPHYLACTICS (January 16, 1980)

Other clearances for product code KMJ

  • K142473 — Lubricating Jelly (April 13, 2015)
  • K141028 — COLONGLIDE LUBRICANT (July 24, 2014)
  • K131617 — COLONGLIDE(R) LUBRICANT (October 3, 2013)
  • K121390 — LUBE JELLY SURINGE (August 10, 2012)
  • K113689 — DUKAL LUBRICATING JELLY (May 4, 2012)
  • K112110 — STERILE LUBRICATING JELLY (April 10, 2012)
  • K103718 — DYNACOR LUBRICATION GEL (May 10, 2011)
  • K101522 — ULTRA SEAL STERILE LUBRICATING JELLY (December 23, 2010)
  • K092488 — DYNAREX STERILE LUBRICATING JELLY (December 18, 2009)
  • K083189 — STERI-LUB LUBRICATION GEL (November 21, 2008)

FDA data resources