FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POUCH, TYVEK-POLYMYLON
K Number: K770945
·
Decision Jun 29, 1977
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
63
Applicant Total
6
Review Days
35
Basic Information
- Device Name
- POUCH, TYVEK-POLYMYLON
- K Number
- K770945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL DISPOSABLES INTL., INC.
- Date Received
- May 25, 1977
- Decision Date
- June 29, 1977
- Product Code
- FPK
- 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 |
|---|---|---|---|
| FPK | Tubing, Fluid Delivery | FDA class 2 | General Hospital |
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Other Clearances by MEDICAL DISPOSABLES INTL., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K771231 | ARTEOIAL LINE KIT | Aug 16, 1977 | Substantially Equivalent |
| K771230 | PERCUTANEOUS INTRODUCER SHEATH SET | Aug 16, 1977 | Substantially Equivalent |
| K770699 | NEEDLE SET, A-V FISTULA | Jun 14, 1977 | Substantially Equivalent |
| K770552 | CATHETER, KIDNEY DIALYSIS, HEMO-CATH II | Mar 30, 1977 | Substantially Equivalent |
| K761078 | HEMO-CATH I, KIDNEY DIALYSIS CATHETER | Dec 6, 1976 | Substantially Equivalent |