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510(k) K842547

WET-STOP by Palco Laboratories, Inc. — Product Code KPN

K842547 is an FDA 510(k) premarket notification submitted by Palco Laboratories, Inc. for the device "WET-STOP". The FDA issued a decision of Substantially Equivalent on October 19, 1984. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. Palco Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1984
Date Received
July 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Conditioned Response Enuresis
Device Class
Class II
Regulation Number
876.2040
Review Panel
GU
Submission Type

Other clearances by Palco Laboratories, Inc.

  • K942810 — PALCO LABS COLD POUCH (June 28, 1995)
  • K943842 — PULSE OXIMETER MODEL 305 (March 24, 1995)
  • K920066 — PALCO LABS MODEL 340 PULSE OXIMETER (March 16, 1993)
  • K913694 — PALCO LABS LOADMATIC (December 17, 1991)
  • K911191 — PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR (June 10, 1991)
  • K904988 — PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR (March 18, 1991)
  • K872233 — INJECT-EASE (September 4, 1987)
  • K833344 — AUTO-LANCET (November 7, 1983)

Other clearances for product code KPN

  • K130951 — SIM (August 22, 2013)
  • K971442 — HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,M (January 8, 1998)
  • K971855 — POTTY PAL AND FOREVER-DRY (August 18, 1997)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)
  • K962416 — DRYTIME FOR BLADDER CONTROL SILENT (July 22, 1996)
  • K955338 — DRYTIME FOR POTTY TRAINING (March 12, 1996)
  • K943559 — REMOTE A'LERT (May 24, 1995)
  • K943558 — PRO'TECT (May 24, 1995)
  • K942057 — FISHER-PRICE DRY NIGHT MONITOR (July 28, 1994)
  • K935915 — WET SENSE (May 13, 1994)

FDA data resources