FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL VIDEO/LASER ARM DRAPE
K Number: K934630
·
Decision Oct 28, 1994
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
449
Applicant Total
13
Review Days
399
Basic Information
- Device Name
- UNIVERSAL VIDEO/LASER ARM DRAPE
- K Number
- K934630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HYDRO-MED PRODUCTS, INC.
- Date Received
- September 24, 1993
- Decision Date
- October 28, 1994
- 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 | FDA class 2 | General, Plastic Surgery |
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Other Clearances by HYDRO-MED PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K923099 | X-RAY DRAPES | Oct 15, 1992 | Substantially Equivalent |
| K863872 | TAMPER HAMPER | Feb 10, 1987 | Substantially Equivalent |
| K853281 | EASYTOP | Aug 21, 1985 | Substantially Equivalent |
| K842304 | THE PATHFINDER | Aug 1, 1984 | Substantially Equivalent |
| K834407 | STERILE DISPOSABLE SPINAL NEEDLES | Mar 19, 1984 | Substantially Equivalent |
| K812405 | STERILE TV CAMERA & CORD COVER | Oct 20, 1981 | Substantially Equivalent |
| K790659 | INFANT SCALE DISPOSABLE LINER | Apr 30, 1979 | Substantially Equivalent |