The following data is part of a premarket notification filed by Kevtek Medical Products, Inc. with the FDA for Kevtek(tm) Laser Drape/organ Protector/eye Shield.
| Device ID | K902000 |
| 510k Number | K902000 |
| Device Name: | KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD |
| Classification | Curette, Surgical, General Use |
| Applicant | KEVTEK MEDICAL PRODUCTS, INC. P.O. BOX 580644 Houston, TX 77258 |
| Contact | Weinberg, Phd |
| Correspondent | Weinberg, Phd KEVTEK MEDICAL PRODUCTS, INC. P.O. BOX 580644 Houston, TX 77258 |
| Product Code | FZS |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-02 |
| Decision Date | 1990-08-21 |