The following data is part of a premarket notification filed by Specialty Fibres And Materials Ltd. with the FDA for Suprasorb A +ag.
| Device ID | K071442 |
| 510k Number | K071442 |
| Device Name: | SUPRASORB A +AG |
| Classification | Dressing, Wound, Drug |
| Applicant | SPECIALTY FIBRES AND MATERIALS LTD. 101, LOCKHURST LN. Coventry, GB Cv6 5rs |
| Contact | Colin Ludford |
| Correspondent | Colin Ludford SPECIALTY FIBRES AND MATERIALS LTD. 101, LOCKHURST LN. Coventry, GB Cv6 5rs |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-05-23 |
| Decision Date | 2008-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825439012215 | K071442 | 000 |
| 00825439012192 | K071442 | 000 |
| 00825439012178 | K071442 | 000 |
| 00825439012154 | K071442 | 000 |