510(k) K862478
- Device
- HAYES VAGINAL SHIELD
- Applicant
- FRANKLIN MEDICAL USA, INC.
- 510(k) number
- K862478
- Product code
- HDF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-24
- Date received
- 1986-06-30
- Regulation
- 884.4520
- Classification name
- Speculum, Vaginal, Metal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HAYES, M.D.
- Address
- 26206 W. 12 Mile Rd. Suite 200 Southfield MI US 48034 48034
FDA Registration Numbers#
- 3006059835
- 3013557562
- 1057946
- 3003759558
- 9710524
- 8040263
- 3004122598
- 9680563
- 3008280196
- 3007648354
- 9680519
- 3010055973
- 3004530184
- 3012226300
- 3039414397
- 2246990
- 9616246
- 8040233
- 3015895045
- 3027556548
- 3007389672
- 3003032798
- 3013784566
- 1421101
- 1054241
- 3005273623
- 3019404837
- 9680260
- 3031564283
- 3008770252
- 9613563
- 3002769835
- 3007773213
- 3009865268
- 3006410968
- 3006554912
- 3009340886
- 3003905396
- 1030451
- 1836161
- 3012507533
- 1055890
- 3005587147
- 3004892425
- 3003956316
- 3003244954
- 3010399422
- 9610612
- 3015140199
- 3010288346
- 3009703496
- 9616088
- 1417592
- 8010935
- 8040373
- 3008902714
- 3011371465
- 3010829427
- 2320762
- 8030607
- 9612074
- 3007878094
- 3003536766
- 8043752
- 3002807115
- 8010482
- 3003418325
- 3008719017
- 3036795921
- 8040881
- 3010687973
- 1056350
- 3045853999
- 8043622
- 3005194291
- 3014615697
- 9614062
- 3005809810
- 2511556
- 3000126234
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HDF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Thomasville Medical Assoc. | 1994-02-28 |
| K902019 | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS | Gynescope Corp. | 1990-06-07 |
| K891041 | MIYA SPECULUM | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| K891044 | LASER SPECULA | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K890375 | VAGINAL SPECULUM | Kinetic Medical Products | 1989-02-13 |
| K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL | Downs Surgical , Ltd. | 1985-10-29 |
| K851799 | 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA | Artiberia | 1985-05-22 |
| K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN | Downs Surgical , Ltd. | 1984-10-01 |
| K821291 | PEDERSON VAGINAL SPECULA | Conphar, Inc. | 1982-05-24 |
| K821297 | GRAVES SPECULA | Conphar, Inc. | 1982-05-24 |
Legacy Summary#
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FDA Review#
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