FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREAST SHELLS
K Number: K923577
·
Decision Jan 22, 1993
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
11
Applicant Total
19
Review Days
186
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Basic Information
- Device Name
- BREAST SHELLS
- K Number
- K923577
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5630
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medela, Inc.
- Date Received
- July 20, 1992
- Decision Date
- January 22, 1993
- Product Code
- HFS
- 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 |
|---|---|---|---|
| HFS | Shield, Nipple | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HFS), ordered by most recent decision date.
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COMFORT PLUS BREAST SHELLS
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COMFORT PLUS NIPPLE SHIELDS
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BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS
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FDA Class 1
·General Hospital
GENTLE FEEL
FDA 510(k)
FDA Class 1
·General Hospital
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| K950750 | MEDELAS BREAST PUMP | Oct 16, 1995 | Substantially Equivalent |
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| K901344 | MEDELA BATTERY OPERATED BREAST PUMP | Aug 6, 1990 | Substantially Equivalent |