The following data is part of a premarket notification filed by Preferred Medical Products with the FDA for Ob/gyn Drape.
| Device ID | K920808 |
| 510k Number | K920808 |
| Device Name: | OB/GYN DRAPE |
| Classification | Drape, Surgical |
| Applicant | PREFERRED MEDICAL PRODUCTS 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook PREFERRED MEDICAL PRODUCTS 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-21 |
| Decision Date | 1993-02-19 |