The following data is part of a premarket notification filed by Alastair Granville-jackson, Mfa, Ed.d. with the FDA for Dynasty Hearing Systems Instrument.
| Device ID | K900632 |
| 510k Number | K900632 |
| Device Name: | DYNASTY HEARING SYSTEMS INSTRUMENT |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ALASTAIR GRANVILLE-JACKSON, MFA, ED.D. CHATHAM SQUARE MEDICAL OFFICES 11 EAST 17TH STREET, 6TH FL. New York, NY 10003 |
| Contact | Granville-jackson |
| Correspondent | Granville-jackson ALASTAIR GRANVILLE-JACKSON, MFA, ED.D. CHATHAM SQUARE MEDICAL OFFICES 11 EAST 17TH STREET, 6TH FL. New York, NY 10003 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-08 |
| Decision Date | 1990-09-12 |