FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
PROCEDURE KIT/ROUTINE DENTAL PROCEDURES
K Number: K905461
·
Decision Mar 5, 1991
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
30
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- PROCEDURE KIT/ROUTINE DENTAL PROCEDURES
- K Number
- K905461
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Unknown
- Applicant
- Angiosystems, Inc.
- Date Received
- December 5, 1990
- Decision Date
- March 5, 1991
- Product Code
- EKS
- 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 |
|---|---|---|---|
| EKS | File, Pulp Canal, Endodontic | FDA class 1 | Dental |
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Other Clearances by Angiosystems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905464 | MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING | May 31, 1991 | Unknown |
| K905459 | SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM | Apr 5, 1991 | Substantially Equivalent |
| K905466 | STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE | Feb 11, 1991 | Substantially Equivalent |
| K905465 | STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE | Feb 11, 1991 | Substantially Equivalent |
| K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | Feb 6, 1991 | Substantially Equivalent |
| K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | Feb 6, 1991 | Substantially Equivalent |
| K905463 | GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION | Jan 22, 1991 | Unknown |
| K864688 | ARNOLD-KING PRESSURE DRESSING | Jan 12, 1987 | Substantially Equivalent |
| K843258 | ANGIO SYS BRACHIAL ANGIO DRAPE | Sep 21, 1984 | Substantially Equivalent |
| K843259 | ANGIO SYS FLUOROSCOPE DRAPE | Sep 21, 1984 | Substantially Equivalent |