Home / 510(k) Clearances / K853880

510(k) K853880

ATTENDS DISPOS. UNDERPAD by Procter & Gamble Mfg. Co. — Product Code KME

K853880 is an FDA 510(k) premarket notification submitted by Procter & Gamble Mfg. Co. for the device "ATTENDS DISPOS. UNDERPAD". The FDA issued a decision of Substantially Equivalent on October 16, 1985. 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
October 16, 1985
Date Received
September 18, 1985
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.

  • K873036 — ATTENDS INCONTINENT BRIEF (January 19, 1988)
  • K873457 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (January 19, 1988)
  • K864673 — UNSCENTED MENSTRUAL PAD (January 21, 1987)
  • K861863 — MODIFIED PROTECTIVE GARMENT (August 11, 1986)
  • K862348 — SINGLE-USE PATIENT UNDERPAD (July 2, 1986)
  • K860598 — MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS (March 5, 1986)
  • K853000 — SCENTED ALWAYS PANTILINERS (September 6, 1985)
  • K852985 — UNSCENTED ALWAYS PANTILINERS (August 29, 1985)
  • K850940 — ALWAYS SUPER MAXIPAD-UNSCENTED (May 14, 1985)
  • K850939 — ALWAYS SUPER MAXIPAD-SCENTED (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