FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
K Number: K880650
·
Decision Feb 24, 1988
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
505
Review Days
7
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Basic Information
- Device Name
- HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
- K Number
- K880650
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Baxter Healthcare Corp
- Date Received
- February 17, 1988
- Decision Date
- February 24, 1988
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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