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510(k) K822754

EAR/ULCER SYRINGE by American Hospital Supply Corp. — Product Code KCP

K822754 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "EAR/ULCER SYRINGE". The FDA issued a decision of Substantially Equivalent on October 4, 1982. The device falls under product code KCP (Syringe, Ent), a Class I device regulated under 21 CFR 874.5220. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1982
Date Received
September 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Ent
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by American Hospital Supply Corp.

  • K854739 — AMERICAN STERILE SURGICAL ABSORBENT TOWEL (December 27, 1985)
  • K854759 — AMERICAN STERILE MAYO STAND TRAY (December 17, 1985)
  • K832826 — AAP DOSIMETRY RELEASE OR BASIN SETS (April 23, 1984)
  • K830546 — DOSIMETRIC RELEASE (May 25, 1983)
  • K822990 — CONVERTORS PRIMARY WOUND DRESSING II (April 12, 1983)
  • K830343 — CONTAINER W/PRIMING SOLUTION (March 17, 1983)
  • K830301 — STRATUS FLUOROMETRIC ENZYME IMMUN0- (February 25, 1983)
  • K822755 — LATEX PENROSE TUBING (January 21, 1983)
  • K823418 — HEYER-SCHUTE UNIVERSAL URETERAL STENT (December 3, 1982)
  • K822966 — CONVERTORS DISPOSABLE DRESSING SPONGE (November 5, 1982)

Other clearances for product code KCP

  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K810284 — AUTOMATIC TEFLON INJECTION SYRINGE (March 11, 1981)
  • K780599 — SYRINGE, EAR & ULCER (April 19, 1978)

FDA data resources