FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DILATOR, MIZUTANI LAMINARIA TENT
K Number: K782067
·
Decision Jan 3, 1979
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
2
Review Days
21
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Basic Information
- Device Name
- DILATOR, MIZUTANI LAMINARIA TENT
- K Number
- K782067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4260
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- British Marketing Ent., Ltd.
- Date Received
- December 13, 1978
- Decision Date
- January 3, 1979
- Product Code
- HDY
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDY), ordered by most recent decision date.
ATAD ARD CATHETER
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LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
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MMODIFICATION TO LAMINARIA
FDA 510(k)
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·Obstetrics/Gynecology
LAMINARIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAMINARIA TENT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LAMINARIA CUREX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by British Marketing Ent., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K790032 | DISPOSABLE VACUUM CURETTE | Feb 1, 1979 | Substantially Equivalent |