510(k) K841515
K841515 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN VASCU-STATT II". The FDA issued a decision of Substantially Equivalent on June 5, 1984. The device falls under product code HRG (Engine, Trephine, Accessories, Ac-Powered), a Class I device regulated under 21 CFR 886.4070. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 1984
- Date Received
- April 12, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Engine, Trephine, Accessories, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.4070
- Review Panel
- OP
- Submission Type