The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Hcs 2000 Uretheral Warmer Catheter.
| Device ID | K955011 |
| 510k Number | K955011 |
| Device Name: | CANDELA HCS 2000 URETHERAL WARMER CATHETER |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CANDELA LASER CORP. 555 THIRTEENTH STREET, N.W Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan CANDELA LASER CORP. 555 THIRTEENTH STREET, N.W Washington, DC 20004 -1109 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-01 |
| Decision Date | 1996-04-03 |
| Summary: | summary |