510(k) K812102
K812102 is an FDA 510(k) premarket notification submitted by Latex Medical Devices, Inc. for the device "O.N.A.T.". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Latex Medical Devices, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1981
- Date Received
- July 24, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type