510(k) K800703
K800703 is an FDA 510(k) premarket notification submitted by Hancock Laboratories, Inc. for the device "MODIFIED CATHETER PACKAGE". The FDA issued a decision of Substantially Equivalent on April 8, 1980. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Hancock Laboratories, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1980
- Date Received
- March 27, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type