510(k) K800162
K800162 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "ONCE TM". The FDA issued a decision of Substantially Equivalent on Feb 11, 1980. The device falls under product code HDW (Diaphragm, Contraceptive (And Accessories)), a Class II device regulated under 21 CFR 884.5350. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 1980
- Date Received
- Jan 25, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Diaphragm, Contraceptive (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.5350
- Review Panel
- OB
- Submission Type
- 510(k)