510(k) K980096
- Device
- OAC (OPTICAL ASPIRATING CURETTE)
- Applicant
- IMAGYN MEDICAL TECHNOLOGIES, INC.
- 510(k) number
- K980096
- Product code
- HCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-05-01
- Date received
- 1998-01-09
- Regulation
- 884.4530
- Classification name
- Curette, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD H BERGESON
- Address
- 27651 La Paz Rd. Laguna Niguel CA US 92677 92677
FDA Registration Numbers#
- 9616088
- 3009148458
- 1061124
- 3008808049
- 3010155661
- 9616250
- 8044098
- 9681540
- 3043355002
- 3005809810
- 2020550
- 3033536312
- 9613079
- 3011137372
- 3010455030
- 3010202439
- 3004168759
- 3003431869
- 9614068
- 1924066
- 9611112
- 3008338766
- 3007681502
- 2521453
- 3008902714
- 3015895045
- 9614062
- 3009513193
- 3023657851
- 1417592
- 3035678069
- 1720747
- 3015972835
- 3009746061
- 9611610
- 9680519
- 9681622
- 3013557562
- 3014615697
- 3012322232
- 9611283
- 3008004502
- 3004215117
- 2511556
- 3010041511
- 8040278
- 9710524
- 3029082594
- 3009340886
- 2183650
- 3007137643
- 1836161
- 1923569
- 9610905
- 1450908
- 2916714
- 3004127962
- 9680518
- 2433012
- 3036795921
- 2244900
- 9616246
- 1421879
- 3013497507
- 1216677
- 3043533459
- 3003877407
- 1421101
- 1424478
- 3006389770
- 8010155
- 2246552
- 3003418325
- 3003620648
- 1412854
- 9612074
- 8010251
- 3005194291
- 3005440795
Source Documents#
Other 510(k) Records For Product Code HCY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944238 | ENDOCYTE TM | D.L. Nelson and Assoc., Inc. | 1995-09-15 |
| K935822 | PHASE I CURETTE | Phase I Corp. | 1994-04-28 |
| K901442 | BAXTER D & C TRAY | Baxter Healthcare Corp | 1990-07-26 |
| K890384 | UTERINE CURETTE | Kinetic Medical Products | 1989-02-13 |
| K881794 | IVORY FINDER SET | Ivory Instruments Co. | 1988-07-08 |
| K862297 | THE D & C PAD-SAC | Nu-Gyn-Tek, Inc. | 1986-07-07 |
| K850068 | LUNE AU CURETTES | Luneau Laboratories | 1985-04-08 |
| K841004 | SURGICAL CURETTE, VARIOUS | Premier Dental Products Co. | 1984-05-11 |
| K802313 | UTERINE CURETTE | Gynemetrics, Inc. | 1981-01-12 |
| K790032 | DISPOSABLE VACUUM CURETTE | British Marketing Ent., Ltd. | 1979-02-01 |
Legacy Summary#
summary
FDA Review#
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