FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GETTIG STYRL-JECT DELIVERY SYSTEM
K Number: K972285
·
Decision Sep 11, 1997
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
5
Review Days
84
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Basic Information
- Device Name
- GETTIG STYRL-JECT DELIVERY SYSTEM
- K Number
- K972285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gettig Pharmaceutical Instrument Co.
- Date Received
- June 19, 1997
- Decision Date
- September 11, 1997
- 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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Other Clearances by Gettig Pharmaceutical Instrument Co.
| K Number | Device Name | ||
|---|---|---|---|
| K041232 | GETTIG UNIVERSAL VIAL ACCESS PIN | Jul 22, 2004 | Substantially Equivalent |
| K033409 | AMERSHAM HEALTH NEEDLE-GUARD | Jan 21, 2004 | Substantially Equivalent |
| K022495 | GETTIG DISPOSABLE SYRINGES | Oct 8, 2002 | Substantially Equivalent |
| K000455 | GETTIG GUARD | Apr 19, 2000 | Substantially Equivalent |