FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE
K Number: K905466
·
Decision Feb 11, 1991
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
14
Review Days
68
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Basic Information
- Device Name
- STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE
- K Number
- K905466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Angiosystems, Inc.
- Date Received
- December 5, 1990
- Decision Date
- February 11, 1991
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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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 |
| K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | Mar 5, 1991 | Unknown |
| 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 |