FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASTER-GUARD
K Number: K884041
·
Decision Oct 7, 1988
Classifications
1
FEI Numbers
265
Registration Numbers
265
Same Product Code
270
Applicant Total
6
Review Days
11
Basic Information
- Device Name
- MASTER-GUARD
- K Number
- K884041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- SPARCO, INC.
- Date Received
- September 26, 1988
- Decision Date
- October 7, 1988
- Product Code
- KCT
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
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Other Clearances by SPARCO, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K863964 | LIMB-GUARD | Oct 24, 1986 | Substantially Equivalent |
| K850268 | SPARCO SCOPE GUARD | Apr 15, 1985 | Substantially Equivalent |
| K850267 | SPARCO PIGGY-BACK POLE-INTRAVENOUS TRANSPORT POLE | Feb 27, 1985 | Substantially Equivalent |
| K844286 | FLASH GUARD PLASTIC VERSION | Nov 19, 1984 | Substantially Equivalent |
| K841669 | FLASH GUARD | Jun 5, 1984 | Substantially Equivalent |