FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LAPAROTOMY SPONGES, STERILE
K Number: K771395
·
Decision Aug 19, 1977
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
238
Review Days
22
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Basic Information
- Device Name
- LAPAROTOMY SPONGES, STERILE
- K Number
- K771395
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medline Industries, Inc.
- Date Received
- July 28, 1977
- Decision Date
- August 19, 1977
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
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KENSORB
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TRIANGULAR SPONGES
FDA 510(k)
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