The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Nd:yag Laser Spectacles, Mst Model #yls-5.
| Device ID | K883839 |
| 510k Number | K883839 |
| Device Name: | ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 |
| Classification | Snake Bite Suction Kit |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Scott C Marlow |
| Correspondent | Scott C Marlow MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | KYP |
| CFR Regulation Number | 880.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-12 |
| Decision Date | 1988-12-09 |