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510(k) K822059

SHOW'RBAG by The Healthcare Group Laboratories, Inc. — Product Code LGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1982
Date Received
July 13, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Cast
Device Class
Class I
Regulation Number
888.5940
Review Panel
OR
Submission Type

Other clearances by The Healthcare Group Laboratories, Inc.

  • K850035 — EMPTY SOLUTION TRANSFER CONTAINER (June 7, 1985)
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  • K842091 — DISPOS. ACU-CUT SOFT TISSUE BIOPSY (July 23, 1984)
  • K840742 — RIGHT ATRIAL CATHETER (July 13, 1984)
  • K830299 — SOLUTION TRANSFER CONTAINER (February 19, 1983)
  • K822307 — ADHESIVE SPRAY #4050-4060 (September 24, 1982)
  • K821480 — RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT (June 17, 1982)
  • K821230 — SOFTIC 49 (May 28, 1982)
  • K821162 — ADHESIVE REMOVER (May 14, 1982)
  • K821161 — EXTERNAL URINARY MALE INCONTINENCE DEV (May 10, 1982)

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  • K932507 — QUICK-CAST IMMOBILIZER (February 23, 1994)
  • K931672 — CARAPACE STERILE CAST PADDING (December 15, 1993)
  • K910274 — ARTIFLEX(TM) (March 5, 1991)
  • K903946 — COOL CAST(R) (December 31, 1990)
  • K896634 — CARAGLAS XTRA SYNTHETIC CASTING TAPE (June 14, 1990)
  • K883294 — SYNTHETIC CAST TAPE (August 30, 1988)