FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ACU-PUNCH
K Number: K831635
·
Decision Jul 7, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
13
Review Days
48
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Basic Information
- Device Name
- ACU-PUNCH
- K Number
- K831635
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Acuderm, Inc.
- Date Received
- May 20, 1983
- Decision Date
- July 7, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- PA
- Third Party
- N
Other Clearances by Acuderm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933516 | ACU-E PUNCH | Mar 24, 1994 | Substantially Equivalent |
| K933265 | ACU-DISPO-CE(TM) | Mar 7, 1994 | Substantially Equivalent |
| K933137 | ACU-SUTURE KIT | Feb 22, 1994 | Substantially Equivalent |
| K930043 | ACU-EVAC | Feb 9, 1994 | Substantially Equivalent |
| K933866 | ACU-HEMOSTATIC RING | Dec 1, 1993 | Substantially Equivalent |
| K915000 | ACU-GUARD | Jan 27, 1992 | Substantially Equivalent |
| K891334 | ACU-CURETTE | Apr 11, 1989 | Substantially Equivalent |
| K874024 | ACU-MICRO-NEEDLE | Nov 23, 1987 | Substantially Equivalent |
| K854877 | ACU-SYRINGE W/WO NEEDLES | Feb 19, 1986 | Substantially Equivalent |
| K832582 | MYCOSEL AGAR | Sep 12, 1983 | Substantially Equivalent |