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510(k) K760995

DECOLLATING TRAY by Dravon Medical, Inc. — Product Code FJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1977
Date Received
November 8, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Declotting Tray, Kit (Including Contents)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K812772 — PERITONEAL DIALYSIS CYCLER SET (8UNIT) (October 19, 1981)
  • K812771 — PERITONEAL DIALYSIS DRAINAGE (October 19, 1981)
  • K811851 — S-610 SHUNT ADAPTOR SET (August 31, 1981)
  • K800435 — HEMOSTATIC/TUBE OCCLUDING FORCEPS (March 12, 1980)
  • K782057 — CATHETER, RADIOPAQUE TENCKHOFF (February 27, 1979)
  • K782058 — CATHETER, BETA-CAP-PERITONEAL (February 27, 1979)

Other clearances for product code FJZ

  • K821313 — SURGICAL UTILITY DRAPE (June 21, 1982)
  • K821666 — STERILE SURGICAL DRAPES (June 21, 1982)