510(k) K890022
K890022 is an FDA 510(k) premarket notification submitted by Alpha-Tec Systems, Inc. for the device "ATS MAYER'S ALBUMIN". The FDA issued a decision of Substantially Equivalent on January 10, 1989. The device falls under product code KEL (Adhesive, Albumin-Based), a Class I device regulated under 21 CFR 864.4010. Alpha-Tec Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1989
- Date Received
- January 4, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Albumin-Based
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type