510(k) K770476
K770476 is an FDA 510(k) premarket notification submitted by General Medical Co. for the device "EXAM GOWN". The FDA issued a decision of Substantially Equivalent on May 6, 1977. The device falls under product code FME (Gown, Examination), a Class I device regulated under 21 CFR 880.6265. General Medical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1977
- Date Received
- March 11, 1977
- 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