FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K Number: K792541
·
Decision Feb 1, 1980
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
191
Review Days
53
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Basic Information
- Device Name
- MONOJECT PLASTIC DENTAL INJ. SYRINGE
- K Number
- K792541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Co.
- Date Received
- December 10, 1979
- Decision Date
- February 1, 1980
- Product Code
- EJI
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EJI | Syringe, Cartridge | FDA class 2 | Dental |
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| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |