510(k) K926425
- Device
- AMNIPERF(TM)
- Applicant
- Raymart Development Co.
- 510(k) number
- K926425
- Product code
- HGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-07
- Date received
- 1992-12-23
- Regulation
- 884.4530
- Classification name
- Amniotome
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- DENNIS L NELSON
- Address
- C/O D.L. Nelson &M Associates 2902 Marlin Cir. Atlanta GA US 30341 30341
FDA Registration Numbers#
- 3008711893
- 9611004
- 2433012
- 8010422
- 3005273623
- 3030733800
- 3015060216
- 3010155661
- 5906
- 3015238043
- 3012551896
- 3014926389
- 1060680
- 1216677
- 3012494290
- 3005809810
- 3018071447
- 3035708926
- 3013557562
- 8043769
- 2246552
- 3003418325
- 1820334
- 9612074
- 8040278
- 9611112
- 3014579161
- 3008338766
- 1054241
- 3018762668
- 1836161
- 9680787
- 1718873
- 1043214
- 1057404
- 1055236
- 2320762
- 9610612
- 9680254
- 1450908
- 2916714
- 3030446844
- 3004127962
- 1825146
- 1422634
- 1319639
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HGE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951148 | OBSTI-HOOK | Onli | 1995-06-09 |
| K910518 | GLOVE-N-GEL AMNIOTOMY KIT | Epcom Medical Systems, Inc. | 1991-05-09 |
| K871087 | S.C.M.T. PERFORATOR | Salt Creek Medical Technologies | 1987-03-23 |
| K850758 | AMNIGLOVE & AMNICOT | Go Medical Industries Pty. , Ltd. | 1985-04-15 |
| K834177 | H.R. JAKOBI SURG. INSTRUMENTS #4 30/31 | Imm Enterprises , Ltd. | 1983-12-27 |