Submission Details
| 510(k) Number | K863162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 1986 |
| Decision Date | August 29, 1986 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
VACU-GUARD
Aug 1986
Decision
11d
Days
—
Risk
About This 510(k) Submission
K863162 is an FDA 510(k) clearance for the VACU-GUARD, submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on August 29, 1986, 11 days after receiving the submission on August 18, 1986. This device falls under the General & Plastic Surgery review panel.
Device Classification
| Product Code | — |
| Device Class | — |
Manufacturer
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