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#
- 3030516433
- 3005528784
- 9610905
- 3002250546
- 2182979
- 2183456
- 9611274
- 1928237
- 2132732
- 3036795921
- 1220477
- 3011371465
- 3008911114
- 3006487092
- 9611616
- 9615005
- 1047843
- 3005440795
- 3033536312
- 3007589150
- 3008936260
- 3004608878
- 3014342096
- 1820334
- 3007648354
- 3010757045
- 1644408
- 3012995405
- 9611262
- 9611112
- 3014967149
- 3002807295
- 8010591
- 1423537
- 9611502
- 9680519
- 1211566
- 3004024955
- 3002834291
- 2529846
- 2433012
- 3006546082
- 1923569
- 3005809810
- 3012226300
- 9614945
- 3026820968
- 1644487
- 8010372
- 9610612
- 3018094310
- 8010298
- 9680002
- 8030607
- 3035708926
- 3011547624
- 9613073
- 3001620590
- 3004209178
- 3003923584
- 3013886523
- 3011137372
- 3021453307
- 3028006458
- 1000517406
- 1530530
- 3003923579
- 3012755988
- 3004571672
- 8010665
- 3015546200
- 1723170
- 1926681
- 1219653
- 3012222873
- 3005067367
- 8010155
- 1054811
- 9680619
- 2183744
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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