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510(k) K790659

INFANT SCALE DISPOSABLE LINER by Hydro-Med Products, Inc. — Product Code KME

K790659 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "INFANT SCALE DISPOSABLE LINER". The FDA issued a decision of Substantially Equivalent on April 30, 1979. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1979
Date Received
April 4, 1979
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 Hydro-Med Products, Inc.

  • K944198 — SURGICAL MICROSCOPE DRAPE (November 27, 1994)
  • K940151 — ULTRASOUND PROBE DRAPE (November 14, 1994)
  • K934630 — UNIVERSAL VIDEO/LASER ARM DRAPE (October 28, 1994)
  • K940152 — CAMERA COVER WITH TEAR TIP (October 28, 1994)
  • K923099 — X-RAY DRAPES (October 15, 1992)
  • K863872 — TAMPER HAMPER (February 10, 1987)
  • K853281 — EASYTOP (August 21, 1985)
  • K842304 — THE PATHFINDER (August 1, 1984)
  • K834407 — STERILE DISPOSABLE SPINAL NEEDLES (March 19, 1984)
  • K812405 — STERILE TV CAMERA & CORD COVER (October 20, 1981)

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