510(k) K822817
- Device
- Doce All-in-the-ear Aid
- Applicant
- FIDELTY HEARING INSTRUMENTS, INC.
- 510(k) number
- K822817
- Product code
- FSD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-18
- Date received
- 1982-09-20
- Regulation
- 880.5160
- Classification name
- Binder, Abdominal
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007123908
- 3004777506
- 3010621943
- 3006943846
- 3005951403
- 1422443
- 1062671
- 3024891479
- 3014144875
- 3029952416
- 3004161950
- 3007734888
- 3033519
- 3005237621
- 3023471
- 3007853907
- 3014663650
- 1054236
- 3011120089
- 3004024638
- 3003890514
- 9617759
- 1016498
- 3008114969
- 3004950647
- 3029994331
- 3010160370
- 2031444
- 3017633586
- 9681860
- 3014407894
- 3009410520
- 1511629
- 3005597706
- 3042251612
- 3008903689
- 3027500264
- 9616933
- 3003905499
- 3006227741
- 2529776
- 9617277
- 3010452421
- 3027605322
- 1214422
- 1043214
- 3008863514
- 9617045
- 3011713222
- 3009131011
- 2110898
- 3003849847
- 3007615436
- 9616086
- 3003764610
- 9611956
- 1921846
- 3014672091
- 3016707060
- 1026765
- 3006619688
- 1525724
- 1417592
- 3013436575
- 3012466243
- 2028253
- 3010694026
- 3005037196
- 3006010416
- 1423537
- 3003855936
- 3013502414
- 3010790919
- 3007076137
- 3004511024
- 3021376102
- 3007817069
- 3003546412
- 3004605321
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FSD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K892379 | THE POUCH GROIN & ABDOMINAL STRESS AID | Kuhn Industries | 1989-07-20 |
| K810379 | EARETTE HEARING AID SEARS #8054 | Oticon Corp. | 1981-03-04 |
| K770162 | MATERNITY SUPPORTER | R.G. Moore | 1977-02-09 |
| K760772 | DISPOSABLE ABDOMINAL BINDER | Tecnol New Jersey Wound Care, Inc. | 1976-11-03 |