The following data is part of a premarket notification filed by I M, Inc. with the FDA for Neurological Sponge.
| Device ID | K914600 |
| 510k Number | K914600 |
| Device Name: | NEUROLOGICAL SPONGE |
| Classification | Neurosurgical Paddie |
| Applicant | I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Contact | Bernard E Laderman |
| Correspondent | Bernard E Laderman I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-11 |
| Decision Date | 1992-12-30 |