The following data is part of a premarket notification filed by Medical Wire & Equipment Company (bath) Ltd with the FDA for Medical Wire & Equipment S-transwab (or Sigma-transwab) Liquid Amies Collection And Transport Device.
| Device ID | K103805 |
| 510k Number | K103805 |
| Device Name: | MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE |
| Classification | Device, Specimen Collection |
| Applicant | MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD POTLEY LANE Corsham, Wiltshire, GB Sn13 9rt |
| Contact | David Ellis |
| Correspondent | David Ellis MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD POTLEY LANE Corsham, Wiltshire, GB Sn13 9rt |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-28 |
| Decision Date | 2011-01-25 |
| Summary: | summary |