The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Modification To Model 90-1460 Laser Adapter.
| Device ID | K911523 |
| 510k Number | K911523 |
| Device Name: | MODIFICATION TO MODEL 90-1460 LASER ADAPTER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIFESTREAM INT'L, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan LIFESTREAM INT'L, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-04 |
| Decision Date | 1991-04-22 |