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#
- 3005194291
- 3007389672
- 3023657851
- 9611112
- 3038718579
- 3005440795
- 3007507973
- 8010372
- 3004215117
- 3006410968
- 3019315696
- 3005595283
- 2431166
- 3006059835
- 1421879
- 1056350
- 1061124
- 3009703496
- 3004892425
- 3003038445
- 2511556
- 8040278
- 3002090132
- 8010099
- 3010041511
- 3035678069
- 1923569
- 3010687973
- 3014615697
- 3006487092
- 3008797953
- 3008338766
- 3016825318
- 8040263
- 9681540
- 9611283
- 3015173212
- 3004111573
- 3004598675
- 8040881
- 3004519921
- 3010399422
- 3010055973
- 3003759558
- 2320762
- 8040172
- 3003244954
- 1054241
- 3010699884
- 8043816
- 3009340886
- 3015895045
- 3012507533
- 3009255580
- 8040179
- 3008808049
- 3005273623
- 3001297506
- 3027556548
- 3027605742
- 3002675176
- 3001620590
- 3005587147
- 3004168759
- 8010704
- 3012267976
- 1047429
- 3015451162
- 3015351976
- 8041151
- 1000426080
- 3013358456
- 9680304
- 3004001706
- 1928237
- 1836161
- 8010935
- 3004571672
- 3029082594
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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