The following data is part of a premarket notification filed by Medical Scientific, Inc. with the FDA for Modifcation To: Spyglass Irrigation System.
| Device ID | K071832 |
| 510k Number | K071832 |
| Device Name: | MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM |
| Classification | System, Irrigation, Urological |
| Applicant | MEDICAL SCIENTIFIC, INC. 125 JOHN HANCOCK RD. Taunton, MA 02780 |
| Contact | Paul Nardella Jr |
| Correspondent | Paul Nardella Jr MEDICAL SCIENTIFIC, INC. 125 JOHN HANCOCK RD. Taunton, MA 02780 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-03 |
| Decision Date | 2007-09-18 |
| Summary: | summary |