The following data is part of a premarket notification filed by Harod Enterprises, Inc. with the FDA for Neurosurgical Sponges And Paddles And Neuro Patties And Neurosponges.
| Device ID | K073576 |
| 510k Number | K073576 |
| Device Name: | NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES |
| Classification | Neurosurgical Paddie |
| Applicant | HAROD ENTERPRISES, INC. 4052 INDIAN CREEK ROAD Martinez, GA 30907 |
| Contact | Norris R Harod |
| Correspondent | Norris R Harod HAROD ENTERPRISES, INC. 4052 INDIAN CREEK ROAD Martinez, GA 30907 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-19 |
| Decision Date | 2008-02-22 |
| Summary: | summary |