510(k) K792582
K792582 is an FDA 510(k) premarket notification submitted by Gamma Biologicals, Inc. for the device "POLY-LEC SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code KSI (Lectins And Protectins), a Class II device regulated under 21 CFR 864.9550. Gamma Biologicals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1980
- Date Received
- December 14, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lectins And Protectins
- Device Class
- Class II
- Regulation Number
- 864.9550
- Review Panel
- HE
- Submission Type