The following data is part of a premarket notification filed by Cardinal Health, Inc. with the FDA for Spetzler Scalp Retractor Clamps (various Styles And Sizes).
| Device ID | K090272 |
| 510k Number | K090272 |
| Device Name: | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-2B Mcgaw Park, IL 60085 |
| Contact | Gina Rajterowski |
| Correspondent | Gina Rajterowski CARDINAL HEALTH, INC. 1430 WAUKEGAN ROAD- MPKB-2B Mcgaw Park, IL 60085 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-04 |
| Decision Date | 2009-03-18 |
| Summary: | summary |