The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Suction/irrigator Tubing Kit.
Device ID | K952605 |
510k Number | K952605 |
Device Name: | SUCTION/IRRIGATOR TUBING KIT |
Classification | Tubing, Noninvasive |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
Contact | Richard G Jones |
Correspondent | Richard G Jones SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
Product Code | GAZ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-06 |
Decision Date | 1995-09-15 |