FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MICRO SURGICAL DRILL SYSTEM
K Number: K863627
·
Decision Oct 2, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
15
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Basic Information
- Device Name
- MICRO SURGICAL DRILL SYSTEM
- K Number
- K863627
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Acumed Instruments Corp.
- Date Received
- September 17, 1986
- Decision Date
- October 2, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Acumed Instruments Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K853660 | MICRO SURGICAL DRILL SYSTEM | Sep 24, 1985 | Substantially Equivalent |
| K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM | Sep 24, 1985 | Substantially Equivalent |
| K853659 | POWERED IRRIGATION FOR MICRO SURGICAL DRILL | Sep 24, 1985 | Substantially Equivalent |
| K791891 | ACU-MED RED MISER HEMOTHORAX BLOOD COLL. | Dec 5, 1979 | Substantially Equivalent |
| K791399 | ACU-ALERT | Oct 11, 1979 | Substantially Equivalent |
| K791400 | GASTRIC LAVAGE KIT-DISPOSABLE | Aug 16, 1979 | Substantially Equivalent |
| K790901 | I.V. TUBING ORGANIZER | Jun 27, 1979 | Substantially Equivalent |