510(k) K963986
K963986 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "STP SYSTEM PVA WITH ZINC". The FDA issued a decision of Substantially Equivalent on November 8, 1996. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Sage Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1996
- Date Received
- October 4, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Specimen Collection
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type