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510(k) K821666

STERILE SURGICAL DRAPES by Phoenix Glove Co. — Product Code FJZ

K821666 is an FDA 510(k) premarket notification submitted by Phoenix Glove Co. for the device "STERILE SURGICAL DRAPES". The FDA issued a decision of Substantially Equivalent on June 21, 1982. The device falls under product code FJZ (Declotting Tray, Kit (Including Contents)), a Class II device regulated under 21 CFR 876.5820. Phoenix Glove Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1982
Date Received
June 7, 1982
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 Phoenix Glove Co.

  • K830660 — STERILE SURGICAL DRAPES (March 17, 1983)
  • K821044 — PATIENT PREP KITS/TRAYS-STERILE (June 23, 1982)
  • K821043 — STERILE PATIENT EXAM. GLOVES (May 21, 1982)
  • K801846 — ELECTROCARDIOGRAPH ELECTRODE (September 9, 1980)
  • K781820 — GLOVES, VINYL EXAMINATION (December 7, 1978)

Other clearances for product code FJZ

  • K821313 — SURGICAL UTILITY DRAPE (June 21, 1982)
  • K760995 — DECOLLATING TRAY (January 6, 1977)

FDA data resources