FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL DRAPE
K Number: K873313
·
Decision Sep 4, 1987
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
6
Review Days
18
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Basic Information
- Device Name
- SURGICAL DRAPE
- K Number
- K873313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Medical Technology, Inc.
- Date Received
- August 17, 1987
- Decision Date
- September 4, 1987
- 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 American Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963808 | CHOICE POWERED WHEELCHAIR | Feb 12, 1997 | Substantially Equivalent |
| K905745 | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM | Apr 23, 1992 | Substantially Equivalent |
| K874567 | RESUSCITATOR | Feb 29, 1988 | Substantially Equivalent |
| K874430 | NEEDLE CONTAINER | Jan 4, 1988 | Substantially Equivalent |
| K874360 | PLASTIC TUBING CONNECTOR | Nov 17, 1987 | Substantially Equivalent |