FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEXUAL ASSAULT FORENCIC EVIDENCE KIT
K Number: K772298
·
Decision Mar 2, 1978
Classifications
1
FEI Numbers
364
Registration Numbers
364
Same Product Code
20
Applicant Total
12
Review Days
79
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Basic Information
- Device Name
- SEXUAL ASSAULT FORENCIC EVIDENCE KIT
- K Number
- K772298
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Simpson/Basye, Inc.
- Date Received
- December 13, 1977
- Decision Date
- March 2, 1978
- Product Code
- KXF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KXF | Applicator, Absorbent Tipped, Non-Sterile | FDA class 1 | General Hospital |
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Other Clearances by Simpson/Basye, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926179 | SEDLACEK HANDLE | Mar 25, 1994 | Substantially Equivalent |
| K891352 | MARLOW ANAL SPECULUM | Jun 23, 1989 | Substantially Equivalent |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | May 11, 1989 | Substantially Equivalent |
| K891347 | REID ENDOCERVICAL SPREADER | Mar 29, 1989 | Substantially Equivalent |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Mar 29, 1989 | Substantially Equivalent |
| K891349 | CAMPION CERVICAL HOOK | Mar 29, 1989 | Substantially Equivalent |
| K891348 | CAMPION LASER FORCEPS | Mar 22, 1989 | Substantially Equivalent |
| K870276 | HEATED INSTRUMENT BATH | May 7, 1987 | Substantially Equivalent |
| K862717 | HAND MIRROR (ENDOSCOPE) | Jul 30, 1986 | Substantially Equivalent |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Jul 17, 1986 | Substantially Equivalent |