510(k) K772298
K772298 is an FDA 510(k) premarket notification submitted by Simpson/Basye, Inc. for the device "SEXUAL ASSAULT FORENCIC EVIDENCE KIT". The FDA issued a decision of Substantially Equivalent on March 2, 1978. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025. Simpson/Basye, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1978
- Date Received
- December 13, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Absorbent Tipped, Non-Sterile
- Device Class
- Class I
- Regulation Number
- 880.6025
- Review Panel
- HO
- Submission Type