FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
HOSPITAL KIT DK 117
K Number: K922130
·
Decision May 24, 1993
Classifications
1
FEI Numbers
840
Registration Numbers
840
Same Product Code
43
Applicant Total
7
Review Days
383
Basic Information
- Device Name
- HOSPITAL KIT DK 117
- K Number
- K922130
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- SAVOY MEDICAL SUPPLY CO., INC.
- Date Received
- May 6, 1992
- Decision Date
- May 24, 1993
- Product Code
- MDM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | FDA class 1 | General, Plastic Surgery |
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Other Clearances by SAVOY MEDICAL SUPPLY CO., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K922133 | HOSPITAL KIT SV 105 | Jun 7, 1993 | Unknown |
| K922127 | HOSPITAL KIT GP 103 | Mar 29, 1993 | Unknown |
| K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT | Mar 26, 1993 | Substantially Equivalent |
| K922128 | HOSPITAL KIT EP 104 | Mar 23, 1993 | Unknown |
| K922126 | HOSPITAL KIT ENT 1125 | Jan 21, 1993 | Substantially Equivalent |
| K923283 | SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT | Jan 4, 1993 | Unknown |