The following data is part of a premarket notification filed by American Surgical Sponges with the FDA for American Surgical Sponges/neurosurgical Sponges.
| Device ID | K962807 |
| 510k Number | K962807 |
| Device Name: | AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES |
| Classification | Neurosurgical Paddie |
| Applicant | AMERICAN SURGICAL SPONGES 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula AMERICAN SURGICAL SPONGES 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1997-05-02 |
| Summary: | summary |