The following data is part of a premarket notification filed by Sharplan Industries, Inc. with the FDA for Model 2100 Nd:yag Surgical Laser Urological Indica.
| Device ID | K861046 |
| 510k Number | K861046 |
| Device Name: | MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA |
| Classification | Laser For Gastro-urology Use |
| Applicant | SHARPLAN INDUSTRIES, INC. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Contact | Peter Safir |
| Correspondent | Peter Safir SHARPLAN INDUSTRIES, INC. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-05-02 |