The following data is part of a premarket notification filed by Bu Polysciences Equipment & Trading, Llc with the FDA for Cerdak Basic.
| Device ID | K153138 |
| 510k Number | K153138 |
| Device Name: | Cerdak Basic |
| Classification | Dressing, Wound, Drug |
| Applicant | BU POLYSCIENCES EQUIPMENT & TRADING, LLC 10855 SYMPHONY PARK DR. North Bethesda, MD 20852 |
| Contact | N. T. Umamaheswaran |
| Correspondent | N. T. Umamaheswaran BU POLYSCIENCES EQUIPMENT & TRADING, LLC 10855 SYMPHONY PARK DR. North Bethesda, MD 20852 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-30 |
| Decision Date | 2017-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18903389005323 | K153138 | 000 |
| 18903389005156 | K153138 | 000 |
| 18903389005149 | K153138 | 000 |
| 18903389005132 | K153138 | 000 |
| 18903389005125 | K153138 | 000 |
| 18903389005118 | K153138 | 000 |
| 18903389005101 | K153138 | 000 |
| 18903389005095 | K153138 | 000 |
| 18903389005088 | K153138 | 000 |
| 18903389005071 | K153138 | 000 |
| 18903389005064 | K153138 | 000 |
| 18903389005057 | K153138 | 000 |
| 18903389005040 | K153138 | 000 |
| 18903389005033 | K153138 | 000 |
| 18903389005026 | K153138 | 000 |
| 18903389005163 | K153138 | 000 |
| 18903389005170 | K153138 | 000 |
| 18903389005316 | K153138 | 000 |
| 18903389005309 | K153138 | 000 |
| 18903389005293 | K153138 | 000 |
| 18903389005286 | K153138 | 000 |
| 18903389005279 | K153138 | 000 |
| 18903389005262 | K153138 | 000 |
| 18903389005255 | K153138 | 000 |
| 18903389005248 | K153138 | 000 |
| 18903389005231 | K153138 | 000 |
| 18903389005224 | K153138 | 000 |
| 18903389005217 | K153138 | 000 |
| 18903389005200 | K153138 | 000 |
| 18903389005194 | K153138 | 000 |
| 18903389005187 | K153138 | 000 |
| 58903389005017 | K153138 | 000 |