The following data is part of a premarket notification filed by Avail-southwest Division with the FDA for Sta-put Non-magnetic Instrument Drape Catalog #100-187-00 (16x20), 100-186-00 (16x10), 100-183-00 W/dexter Wrap.
| Device ID | K950830 |
| 510k Number | K950830 |
| Device Name: | STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP |
| Classification | Drape, Surgical |
| Applicant | AVAIL-SOUTHWEST DIVISION 13737 STEMMONS FREEWAY Dallas, TX 75234 |
| Contact | Angel R Diaz |
| Correspondent | Angel R Diaz AVAIL-SOUTHWEST DIVISION 13737 STEMMONS FREEWAY Dallas, TX 75234 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-24 |
| Decision Date | 1995-05-03 |