510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760954Substantially Equivalent

Crowntex Exam. Cape & Gown

Graham Manufacturing Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760954 is the FDA 510(k) clearance record for CROWNTEX EXAM. CAPE & GOWN, a class I device, cleared for Graham Manufacturing Co. on under FDA product code FME (Gown, Examination). FDA records list one 510(k) clearance for Graham Manufacturing Co. As of , FDA records show no recalls naming K760954.

Clearance record

Decision date
Received
(58 days to decision)
Product code
FME Gown, Examination
Regulation
21 CFR 880.6265
Device class
Class I
Review panel
General Hospital
Applicant
Graham Manufacturing Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FME

Trailing 12 months

FDA records hold no clearances under product code FME in the trailing twelve months.

FDA records show no clearances under product code FME in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FME, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260