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510(k) K760995

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

K760995 is an FDA 510(k) premarket notification submitted by Dravon Medical, Inc. for the device "DECOLLATING TRAY". The FDA issued a decision of Substantially Equivalent on January 6, 1977. The device falls under product code FJZ (Declotting Tray, Kit (Including Contents)), a Class II device regulated under 21 CFR 876.5820. Dravon Medical, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Dravon Medical, Inc.

  • K873455 — S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS (September 14, 1987)
  • K860770 — AM-100 I/A AMPAC (April 21, 1986)
  • K832739 — STEDIFLO INFUSION SET (December 22, 1983)
  • K831842 — DRAVON T CLAMP (September 26, 1983)
  • K812771 — PERITONEAL DIALYSIS DRAINAGE (October 19, 1981)
  • K812772 — PERITONEAL DIALYSIS CYCLER SET (8UNIT) (October 19, 1981)
  • K811851 — S-610 SHUNT ADAPTOR SET (August 31, 1981)
  • K800435 — HEMOSTATIC/TUBE OCCLUDING FORCEPS (March 12, 1980)
  • K782058 — CATHETER, BETA-CAP-PERITONEAL (February 27, 1979)
  • K782057 — CATHETER, RADIOPAQUE TENCKHOFF (February 27, 1979)

Other clearances for product code FJZ

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

FDA data resources