The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Sheath Sets.
| Device ID | K950634 |
| 510k Number | K950634 |
| Device Name: | CANDELA SHEATH SETS |
| Classification | Catheter, Percutaneous |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Thomas R Varricchione |
| Correspondent | Thomas R Varricchione CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-13 |
| Decision Date | 1995-03-01 |