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510(k) K870742

AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G by Span-America Medical Systems, Inc. — Product Code KMJ

K870742 is an FDA 510(k) premarket notification submitted by Span-America Medical Systems, Inc. for the device "AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G". The FDA issued a decision of Substantially Equivalent on June 5, 1987. The device falls under product code KMJ (Lubricant, Patient), a Class I device regulated under 21 CFR 880.6375. Span-America Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1987
Date Received
February 25, 1987
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 Span-America Medical Systems, Inc.

  • K972486 — PRESSUREGUARD IV (February 20, 1998)
  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K960188 — PRESSUREGUARD: SELECTCARE (October 2, 1996)
  • K961502 — LUBRICATING JELLY, LOW VISCOSITY (July 18, 1996)
  • K961159 — POWERED LOW AIR LOSS MATTRESS SYSTEM (June 14, 1996)
  • K960620 — PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM (April 25, 1996)
  • K960189 — GEL-T CUSHION (February 7, 1996)
  • K954766 — PRESSURE GUARD ALTERNATING PRESSURE MATTRESS (January 11, 1996)
  • K953503 — PRESSUREGUARD IV (October 24, 1995)
  • K954117 — CUSTOMCARE SEATING SYSTEM (October 13, 1995)

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