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510(k) K862348

SINGLE-USE PATIENT UNDERPAD by Procter & Gamble Mfg. Co. — Product Code KME

K862348 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "SINGLE-USE PATIENT UNDERPAD". The FDA issued a decision of Substantially Equivalent on July 2, 1986. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Procter & Gamble Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1986
Date Received
June 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedding, Disposable, Medical
Device Class
Class I
Regulation Number
880.6060
Review Panel
HO
Submission Type

Other clearances by Procter & Gamble Mfg. Co.

  • K873457 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (January 19, 1988)
  • K873036 — ATTENDS INCONTINENT BRIEF (January 19, 1988)
  • K864673 — UNSCENTED MENSTRUAL PAD (January 21, 1987)
  • K861863 — MODIFIED PROTECTIVE GARMENT (August 11, 1986)
  • K860598 — MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS (March 5, 1986)
  • K853880 — ATTENDS DISPOS. UNDERPAD (October 16, 1985)
  • K853000 — SCENTED ALWAYS PANTILINERS (September 6, 1985)
  • K852985 — UNSCENTED ALWAYS PANTILINERS (August 29, 1985)
  • K850955 — ALWAYS MAXIPADS - UNSCENTED (May 14, 1985)
  • K850940 — ALWAYS SUPER MAXIPAD-UNSCENTED (May 14, 1985)

Other clearances for product code KME

  • K042145 — READY-HEAT BLANKET (September 17, 2004)
  • K944953 — OREX MEDICAL BEDDING (December 2, 1994)
  • K933636 — DISPOSE-A-SHEET (January 26, 1994)
  • K932539 — DOCTOR DOWN --RESCUE WRAP (November 2, 1993)
  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)
  • K912257 — CHEM-SLEEVE B (December 31, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)

FDA data resources