The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Var Aural Grom Ag/s9,sd8.00.28.5/0.2 Ns/s/6823 1.4.
| Device ID | K911613 |
| 510k Number | K911613 |
| Device Name: | VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 |
| Classification | Fluorescent Immunoassay, Tobramycin |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Contact | Brian East |
| Correspondent | Brian East EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Product Code | LCR |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-06-28 |