The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Hearing Aid Impression Material.
| Device ID | K955288 |
| 510k Number | K955288 |
| Device Name: | HEARING AID IMPRESSION MATERIAL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights, NY 10598 |
| Contact | Laurence Colin |
| Correspondent | Laurence Colin CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights, NY 10598 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-16 |
| Decision Date | 1996-02-02 |