The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for 23ga Chandelier Illuminator, 25ga Chandelier Illuminator.
| Device ID | K151604 |
| 510k Number | K151604 |
| Device Name: | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator |
| Classification | Endoilluminator |
| Applicant | PEREGRINE SURGICAL LTD. 51 BRITAIN DRIVE New Britain, PA 18901 |
| Contact | Ryan O'leary |
| Correspondent | Ryan O'leary PEREGRINE SURGICAL LTD. 51 BRITAIN DRIVE New Britain, PA 18901 |
| Product Code | MPA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-15 |
| Decision Date | 2015-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10757770524416 | K151604 | 000 |
| 10757770524386 | K151604 | 000 |