The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Tono-pen Avia Tonometer And Ocu-shiled Tip Cover.
| Device ID | K053430 |
| 510k Number | K053430 |
| Device Name: | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER |
| Classification | Tonometer, Manual |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Penny Layman |
| Correspondent | Penny Layman MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-09 |
| Decision Date | 2006-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559010108 | K053430 | 000 |