FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL MICROSCOPE DRAPE
K Number: K944198
·
Decision Nov 27, 1994
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
14
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- SURGICAL MICROSCOPE DRAPE
- K Number
- K944198
- 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
- August 29, 1994
- Decision Date
- November 27, 1994
- Product Code
- MMP
- 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 |
|---|---|---|---|
| MMP | Cover, Barrier, Protective | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Hydro-Med Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940151 | ULTRASOUND PROBE DRAPE | Nov 14, 1994 | Substantially Equivalent |
| K934630 | UNIVERSAL VIDEO/LASER ARM DRAPE | Oct 28, 1994 | Substantially Equivalent |
| K940152 | CAMERA COVER WITH TEAR TIP | Oct 28, 1994 | Substantially Equivalent |
| 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 |