Submission Details
| 510(k) Number | K040936 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 09, 2004 |
| Decision Date | May 03, 2004 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
May 2004
Decision
24d
Days
Class 1
Risk
About This 510(k) Submission
K040936 is an FDA 510(k) clearance for the PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE, a Bandage, Elastic (Class I — General Controls, product code FQM), submitted by Leda Co., Ltd. (Washington, US). The FDA issued a Cleared decision on May 3, 2004, 24 days after receiving the submission on April 9, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5075.
Device Classification
| Product Code | FQM — Bandage, Elastic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5075 |
Manufacturer
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