510(k) K821617
- Device
- DISPOSABLE HEMOSTATS
- Applicant
- MEDCARE PRODUCTS
- 510(k) number
- K821617
- Product code
- HRQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-21
- Date received
- 1982-06-02
- Regulation
- 878.4800
- Classification name
- Hemostat
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8040373
- 8043554
- 3002834291
- 2936485
- 3002976036
- 8010372
- 3010452421
- 8010257
- 8040278
- 3010041511
- 9680515
- 3008338766
- 3015177648
- 3015173212
- 1720747
- 3010055973
- 8040179
- 3003963832
- 3004215117
- 3002090132
- 3003675041
- 8010370
- 3021680161
- 9680837
- 3015451162
- 1056350
- 3004608878
- 3043355002
- 3010399422
- 3007648354
- 3011585752
- 2242450
- 3005440795
- 1930126
- 3003431869
- 3008711893
- 3011137372
- 3045816907
- 3005809810
- 3004133929
- 3003969055
- 3008489813
- 9680794
- 3005925114
- 1054241
- 1424478
- 3006554912
- 8010591
- 3006891796
- 3005061536
- 3008797953
- 3007518347
- 8044098
- 2087382
- 3006487092
- 3029082594
- 3034688516
- 9681540
- 1055236
- 2648727
- 9680519
- 3004530184
- 9614062
- 9611112
- 3012267976
- 2916714
- 9614075
- 3003644849
- 3010687973
- 3007137643
- 3008770252
- 3012226300
- 3008280196
- 9616088
- 3007597038
- 3003687489
- 1422634
- 3025376090
- 3011767135
- 1828464
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HRQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920298 | DISPOSABLE HEMOSTATS | Falcon Instruments, Inc. | 1992-08-11 |
| K895683 | BERNARD VESSEL APPROXIMATOR | Applied Medical Technologies | 1989-10-24 |
| K890245 | SURGICAL HEMOSTATS | Kinetic Medical Products | 1989-01-27 |
| K884196 | SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) | Disposable Sterile Surgical Instruments, Inc. | 1988-11-08 |
| K881937 | SURGICAL INSTRUMENTS | Far East Intl. Trading Corp. | 1988-06-15 |
| K861807 | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | Medcomp Technologies, Inc. | 1986-05-23 |
| K844152 | HEMSTATS | I M, Inc. | 1984-11-07 |
| K843593 | SURGIPRESS SURGICAL LOOP | Syntex Corp. | 1984-10-24 |
| K841514 | SCANLAN VASCU-STATT II APPROXIMATOR | Scanlan Intl., Inc. | 1984-06-05 |
| K834175 | OP-CON SURG. INSTRUMENTS #11 | Imm Enterprises , Ltd. | 1984-01-27 |
| K831797 | HEMOSTATS | I M, Inc. | 1983-07-19 |
| K823694 | VASCU-STATT APPROXIMATOR | Scanlan Intl., Inc. | 1983-01-07 |
| K822263 | VARIOUS TYPES OF TONSILS HEMOSTATS | Kelleher Corp. | 1982-08-16 |
| K821887 | SCANLAN SUTURE-STATT | Scanlan Intl., Inc. | 1982-07-28 |
Legacy Summary#
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FDA Review#
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