The following data is part of a premarket notification filed by Gel-lite, L.l.c. with the FDA for Various Surgical Or Patient Drapes.
| Device ID | K980210 |
| 510k Number | K980210 |
| Device Name: | VARIOUS SURGICAL OR PATIENT DRAPES |
| Classification | Drape, Surgical |
| Applicant | GEL-LITE, L.L.C. 4820 EXECUTIVE PARKCT., #110 Jacksonville, FL 32216 |
| Contact | Ed Horton |
| Correspondent | Ed Horton GEL-LITE, L.L.C. 4820 EXECUTIVE PARKCT., #110 Jacksonville, FL 32216 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-21 |
| Decision Date | 1998-05-15 |
| Summary: | summary |