The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Ststorz Dp5300 And Dp9502 Sterile Drapes.
| Device ID | K934445 |
| 510k Number | K934445 |
| Device Name: | STSTORZ DP5300 AND DP9502 STERILE DRAPES |
| Classification | Drape, Surgical |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Michael H Southworth |
| Correspondent | Michael H Southworth STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-13 |
| Decision Date | 1994-04-11 |