510(k) K905120
K905120 is an FDA 510(k) premarket notification submitted by Gibson Laboratories, Inc. for the device "SAF FIXATIVE". The FDA issued a decision of Substantially Equivalent on December 17, 1990. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Gibson Laboratories, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1990
- Date Received
- November 14, 1990
- 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