510(k) K852620
K852620 is an FDA 510(k) premarket notification submitted by Ashai Co. , Ltd. for the device "SAFE.N.SURE". The FDA issued a decision of Substantially Equivalent on October 31, 1985. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ashai Co. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1985
- Date Received
- June 20, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type