510(k) K780261
K780261 is an FDA 510(k) premarket notification submitted by Shandon, Inc. for the device "COVERSLIPPER". The FDA issued a decision of Substantially Equivalent on April 18, 1978. The device falls under product code KIM (Device For Sealing Microsections), a Class I device regulated under 21 CFR 864.3400. Shandon, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1978
- Date Received
- February 16, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device For Sealing Microsections
- Device Class
- Class I
- Regulation Number
- 864.3400
- Review Panel
- PA
- Submission Type