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510(k) K821403

LIGHT WEIGHT ALUMINUM CRUTCHES by Manuco Manufacturing Co., Inc. — Product Code IPR

K821403 is an FDA 510(k) premarket notification submitted by Manuco Manufacturing Co., Inc. for the device "LIGHT WEIGHT ALUMINUM CRUTCHES". The FDA issued a decision of Substantially Equivalent on June 21, 1982. The device falls under product code IPR (Crutch), a Class I device regulated under 21 CFR 890.3150. Manuco Manufacturing Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1982
Date Received
May 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crutch
Device Class
Class I
Regulation Number
890.3150
Review Panel
PM
Submission Type

Other clearances by Manuco Manufacturing Co., Inc.

  • K821405 — MAGUN BASE I.V. POLE (June 16, 1982)
  • K821404 — LIGHT WEIGHT ALUMINUM WALKER (May 21, 1982)
  • K821402 — LIGHT WEIGHT ALUMINUM CANES (April 21, 1982)

Other clearances for product code IPR

  • K800237 — FOLDING CRUTCH (February 22, 1980)
  • K790557 — CRUTCH (April 3, 1979)
  • K770146 — SWIVEL HEAD ADJUSTABLE CRUTCH (January 28, 1977)

FDA data resources