FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OBSTETRICAL PACK (VIGILON OB PACK)
K Number: K760455
·
Decision Aug 26, 1976
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
645
Review Days
10
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Basic Information
- Device Name
- OBSTETRICAL PACK (VIGILON OB PACK)
- K Number
- K760455
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- August 16, 1976
- Decision Date
- August 26, 1976
- Product Code
- HHD
- 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 |
|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHD), ordered by most recent decision date.
ALWAYS MENSTRUAL PADS
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FDA Class 1
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ALWAYS DUETS
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FDA Class 1
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ENVIVE MINIFORMS
FDA 510(k)
FDA Class 1
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UNSCENTED INTERLABIAL MENSTRUAL PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
GLADRAGS COTTON MENSTRUAL PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
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