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510(k) K892877

CRADLE, HOSPITAL BED CLOTHING by Warsaw Orthopedic, Inc. — Product Code FNJ

K892877 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "CRADLE, HOSPITAL BED CLOTHING". The FDA issued a decision of Substantially Equivalent on June 15, 1989. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1989
Date Received
April 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Manual
Device Class
Class I
Regulation Number
880.5120
Review Panel
HO
Submission Type

Other clearances by Warsaw Orthopedic, Inc.

  • K883783 — TSRH SACRAL SPINAL SCREW (April 6, 1989)
  • K883784 — TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE (April 6, 1989)
  • K880212 — TSRH H/M HOOK HOLDER W/ROD MOVER (March 4, 1988)
  • K880211 — TSRH H/M HOOK HOLDER (March 4, 1988)
  • K880215 — TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD (February 18, 1988)
  • K880214 — TSRH H/M TORQUE LIMITING WRENCH (February 18, 1988)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (May 27, 1987)
  • K870830 — WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM (May 4, 1987)
  • K870847 — SCHULTZ PHALANGEAL COMPONENT DRIVER (March 13, 1987)

Other clearances for product code FNJ

  • K934298 — KING KRIB (January 26, 1994)
  • K885241 — BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT (February 24, 1989)
  • K884542 — SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED (November 21, 1988)
  • K881725 — ENVIROTENT (BED) (November 8, 1988)
  • K881961 — MSI STANDARD BED MODELS: L1097-64 AND L1085-64 (November 1, 1988)
  • K881964 — MSI 3003 SERIES BED (June 28, 1988)
  • K881962 — MSI 2005 SERIES BED (June 3, 1988)
  • K881043 — FOLDING HOSPITAL COT NSN 6530-00-299-8517 (April 12, 1988)
  • K870166 — PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG (March 13, 1987)
  • K870310 — VSID MEDICAL THREE-FOLDING BED (February 10, 1987)

FDA data resources