510(k) K902850
- Device
- ZEPPELIN INSTRUMENTS
- Applicant
- RUGGLES CORP.
- 510(k) number
- K902850
- Product code
- HAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-18
- Date received
- 1990-06-29
- Regulation
- 882.4535
- Classification name
- Instrument, Surgical, Non-powered
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN RUGGLES
- Address
- 38 Billings Rd. No. Quincy MA US 02171 02171
FDA Registration Numbers#
- 1723170
- 8010155
- 1417592
- 9611815
- 3004209178
- 3011547624
- 8010547
- 3013784566
- 9617544
- 3015425095
- 8010422
- 3010041511
- 3004111573
- 9680515
- 3026820968
- 9611274
- 1416891
- 1820334
- 3012447612
- 3005061536
- 3003923579
- 1412854
- 2183456
- 9613079
- 3006984710
- 3011371465
- 8010877
- 3008285983
- 2182979
- 3001620590
- 3013886523
- 3005621335
- 1833920
- 3012995405
- 3017435639
- 9614084
- 3012322232
- 1836161
- 9681129
- 1056350
- 8010395
- 9611616
- 1526439
- 3008388245
- 3033536312
- 3002250546
- 3004361445
- 9710524
- 3005619998
- 9611502
- 3010052483
- 1935627
- 3004450489
- 9612075
- 3009420598
- 3021453307
- 3018783415
- 1000517406
- 8010405
- 3015546200
- 8010665
- 1828464
- 8030607
- 9611827
- 3012226300
- 8010697
- 3010202439
- 3008902714
- 2027754
- 9610612
- 3004024955
- 1646747
- 3005528784
- 3008534770
- 1644487
- 9614986
- 3014342096
- 9680242
- 9611278
- 9680519
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HAO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220920 | Matreneu Percutaneous Balloon Compression Kit | Shenzhen Shineyard Medical Device Co. , Ltd. | 2022-09-07 |
| K940973 | MULLAN GANGLION MICROCOMPRESSION SET | Cook, Inc. | 1995-09-29 |
| K951492 | RIB RESECTOR | United States Surgical, A Division of Tyco Healthc | 1995-05-18 |
| K943115 | AUTO SUTURE PITUITARY SPINAL RONGEUR | United States Surgical, A Division of Tyco Healthc | 1994-07-25 |
| K942967 | AUTO SUTURE SPINAL CURETTE | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942968 | AUTO SUTURE SPINAL OSTEOTOME | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942969 | AUTO SUTURE SPINAL NERVE HOOK | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942970 | AUTO SUTURE SPINAL ELEVATOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K942971 | AUTO SUTURE SPINAL DISSECTOR | United States Surgical, A Division of Tyco Healthc | 1994-07-20 |
| K923723 | SILICONE BRAIN SPATULA SET | Redmond Neurosurgical, Inc. | 1992-08-12 |
| K910225 | BONE PAD REMOVER | Acra Cut, Inc. | 1991-02-12 |
| K910226 | DURAL DISSECTORS | Acra Cut, Inc. | 1991-02-12 |
| K892546 | TAYLOR SPINAL RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-05-11 |
| K882422 | DISPOSABLE ARACHNOID KNIFE | Microbio-Medics, Inc. | 1988-09-06 |
| K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE | Downs Surgical , Ltd. | 1988-02-11 |
Legacy Summary#
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FDA Review#
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