510(k) K772298

SEXUAL ASSAULT FORENCIC EVIDENCE KIT by Simpson/Basye, Inc. — Product Code KXF

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