510(k) K910555
K910555 is an FDA 510(k) premarket notification submitted by Pfrimmer-Viggo GmbH & Co. for the device "TUTOPLAST DURA". The FDA issued a decision of Substantially Equivalent on April 20, 1992. The device falls under product code LEM (Human Lyophilized Dura Mater), a Class II device regulated under 21 CFR 882.5975.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 1992
- Date Received
- February 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Human Lyophilized Dura Mater
- Device Class
- Class II
- Regulation Number
- 882.5975
- Review Panel
- NE
- Submission Type
Cber review required - previously regulated as a device under 21 cfr 882.5975, now regulated in cber under section 361 as banked human tissue. See definition at §1271.3(d). Subject to donor eligibility, good tissue practice, registration and listing requirements under part 1271" the good tissue practice regulation http://www.Fda.Gov/cber/rules/gtp.Pdf became final effective may 25, 2005. It states that "on january 27, 2004, fda issued an interim final rule excepting human dura mater and human heart valve allografts from the definition of hct/p in § 1271.3(d) (69 fr 3823). Fda stated that, when the comprehensive framework is in place, fda intends that human dura mater and human heart valves will be subject to it, and that fda intends to revoke the interim rule at that time (69 fr 3823 and 3824). With the effective date of this final rule, fda is revoking the interim rule and revising the language in § 1271.3(d)."