The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Disposable Laser Protective Drape For Co2 Laser.
Device ID | K871068 |
510k Number | K871068 |
Device Name: | DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER |
Classification | Drape, Surgical |
Applicant | LIFESTREAM INT'L, INC. 10940 S. WILCREST Houston, TX 77099 |
Contact | Roger Mogill |
Correspondent | Roger Mogill LIFESTREAM INT'L, INC. 10940 S. WILCREST Houston, TX 77099 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-18 |
Decision Date | 1987-05-28 |