FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYRINGE INJECTION GUN DELIVERY KITS
K Number: K890658
·
Decision Oct 3, 1989
Classifications
1
FEI Numbers
165
Registration Numbers
165
Same Product Code
109
Applicant Total
5
Review Days
237
Basic Information
- Device Name
- SYRINGE INJECTION GUN DELIVERY KITS
- K Number
- K890658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- GASTROTECH, INC.
- Date Received
- February 8, 1989
- Decision Date
- October 3, 1989
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by GASTROTECH, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K890629 | ESOPHAGEAL OVERTUBE | May 31, 1989 | Substantially Equivalent |
| K883351 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE | Aug 23, 1988 | Substantially Equivalent |
| K883336 | GASTROSTOMY FEEDING TUBE | Aug 23, 1988 | Substantially Equivalent |
| K862853 | SYRINGE INJECTION GUN | Aug 6, 1986 | Substantially Equivalent for Some Indications |