DEXON DISSECTING SPONGE
FDA 510(k) clearance K914365 · decided 1991-10-23
Clearance details
- K-number
- K914365
- Device name
- DEXON DISSECTING SPONGE
- Applicant
- Davis & Geck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-01
- Decision date
- 1991-10-23
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- GAK
- Device class
- 2
- Regulation number
- 878.4830
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Danbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008) | Davis & Geck, Inc. | 1996-11-15 |
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S007) | Davis & Geck, Inc. | 1996-01-11 |
| NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE (P840041/S006) | Davis & Geck, Inc. | 1996-01-11 |
| NOVAFIL(TM) (P840041/S005) | Davis & Geck, Inc. | 1994-04-20 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S006) | Davis & Geck, Inc. | 1992-03-24 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005) | Davis & Geck, Inc. | 1991-10-17 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S004) | Davis & Geck, Inc. | 1991-03-29 |
| NOVAFIL(TM) (P840041/S003) | Davis & Geck, Inc. | 1990-07-06 |