510(k) K760954
K760954 is an FDA 510(k) premarket notification submitted by Graham Manufacturing Co. for the device "CROWNTEX EXAM. CAPE & GOWN". The FDA issued a decision of Substantially Equivalent on December 30, 1976. The device falls under product code FME (Gown, Examination), a Class I device regulated under 21 CFR 880.6265.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1976
- Date Received
- November 2, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Examination
- Device Class
- Class I
- Regulation Number
- 880.6265
- Review Panel
- HO
- Submission Type