510(k) K821887
K821887 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN SUTURE-STATT". The FDA issued a decision of Substantially Equivalent on July 28, 1982. The device falls under product code HRQ (Hemostat), a Class I device regulated under 21 CFR 878.4800. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1982
- Date Received
- June 25, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemostat
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type